Effect on Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00909857
First received: April 24, 2009
Last updated: January 12, 2014
Last verified: January 2014
  Purpose

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.


Condition Intervention Phase
Primary Dysmenorrhea
Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Drug: Ethinyl estradiol, Levonorgestrel (Miranova)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).


Secondary Outcome Measures:
  • Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)

  • Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

  • Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).

  • Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

  • Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

  • Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

  • Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) [ Time Frame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days) ] [ Designated as safety issue: No ]
    Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).

  • Percentage of Participants Satisfied With Study Treatment [ Time Frame: From cycle 1 to cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Participants were asked to express the degree of their satisfaction with study treatment.

  • Number of Days With Bleeding or Spotting [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Number of Episodes With Bleeding or Spotting [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Mean Length of Bleeding or Spotting Episodes [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Maximum Length of Bleeding or Spotting Episodes [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Number of Days With Spotting-only [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Number of Episodes With Spotting-only [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Mean Length of Spotting Only Episodes [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Maximum Length of Spotting Only Episodes [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Difference in Duration Between Longest and Shortest Spotting Only Episode [ Time Frame: From day 1 to day 90 ] [ Designated as safety issue: No ]
    Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.

  • Percentage of Participants With Withdrawal Bleeding at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Percentage of Participants With Withdrawal Bleeding at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Length of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Length of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.

  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.

  • Onset of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Onset of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Percentage of Participants With Intracyclic Bleeding at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Percentage of Participants With Intracyclic Bleeding at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Number of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Number of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.

  • Number of Intracyclic Bleeding Days at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.

  • Number of Intracyclic Bleeding Days at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.

  • Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At cycle 1 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.

  • Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At cycle 3 (28 days per cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.

  • Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening [ Time Frame: At screening (28 days) ] [ Designated as safety issue: No ]
    The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

  • Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle [ Time Frame: At Baseline (28 days per cycle) ] [ Designated as safety issue: No ]
    The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

  • Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 [ Time Frame: At cycle 2 (28 days per cycle) ] [ Designated as safety issue: No ]
    The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

  • Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.

  • Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire [ Time Frame: At screening (average over 3 months before screening) ] [ Designated as safety issue: No ]
    The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.

  • Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression [ Time Frame: At cycle 2 (28 days per cycle) ] [ Designated as safety issue: No ]
    The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study.

  • Participants With Improvement in Participants' Assessment in the Clinical Global Impression [ Time Frame: At cycle 2 (28 days per cycle) ] [ Designated as safety issue: No ]
    The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study.

  • Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: at final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle [ Time Frame: At baseline cycle (28 days per cycle) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)

  • Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination [ Time Frame: At final examination (28 days) ] [ Designated as safety issue: No ]
    The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)


Enrollment: 507
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
Active Comparator: Ethinyl estradiol, Levonorgestrel (Miranova)
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
Drug: Ethinyl estradiol, Levonorgestrel (Miranova)
Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
  • Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
  • Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
  • Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
  • Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.

Exclusion Criteria:

  • Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
  • Obesity: body mass index (BMI) > 32 kg/m2
  • Hypersensitivity to any of the study drug ingredients
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
  • Abuse of alcohol, drugs, or medicines (e.g. laxatives)
  • Other contraceptive methods:

    • Sterilization
    • Oral, vaginal or transdermal hormonal contraception during treatment
    • Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
  • Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
  • Major surgery scheduled for the study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909857

  Show 44 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00909857     History of Changes
Other Study ID Numbers: 91781, 2008-005625-11, 312042
Study First Received: April 24, 2009
Results First Received: November 15, 2011
Last Updated: January 12, 2014
Health Authority: Canada: Health Canada
Chile : Public Health Institute
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Philippines: Bureau of Food and Drugs
United States: Food and Drug Administration
Venezuela : National Institute of Hygiene Rafael Rangel

Keywords provided by Bayer:
Primary Dysmenorrhea
Oral Contraception

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Dienogest
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on July 29, 2014