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Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)

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ClinicalTrials.gov Identifier: NCT00511199
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : August 29, 2011
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 2, 2007
First Posted Date  ICMJE August 3, 2007
Results First Submitted Date  ICMJE July 28, 2011
Results First Posted Date  ICMJE August 29, 2011
Last Update Posted Date June 6, 2018
Actual Study Start Date  ICMJE May 1, 2006
Actual Primary Completion Date April 1, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 1 year (13 cycles) ]
    In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
  • Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 1 year (13 cycles) ]
    In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
  • Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test). [ Time Frame: One year (13 cycles) ]
  • Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: One year (13 cycles) ]
  • Cycle control as determined by patient [electronic] diaries. [ Time Frame: One year (13 cycles) ]
  • Acceptability will be evaluated on the basis of discontinuation rates and reasons for discontinuation. [ Time Frame: One year (13 cycles) ]
Change History Complete list of historical versions of study NCT00511199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2014)
  • Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
  • Number of Participants With an Occurrence of Absence of Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
  • Number of Participants With an Occurrence of Breakthrough Bleeding [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
  • Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
  • Number of Participants With an Occurrence of Early Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
  • Number of Participants With an Occurrence of Continued Withdrawal Bleeding [ Time Frame: Every 28-day cycle for 12 cycles ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
  • Average Number of Breakthrough Bleeding/Spotting Days [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
  • Average Number of Withdrawal Bleeding/Spotting Days [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
    Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
  • User satisfaction will be evaluated using "Patient Reported Outcome Questionnaires" (self-administered). [ Time Frame: One year (13 cycles) ]
  • Acne will be assessed by regular skin examinations. [ Time Frame: One year (13 cycles) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
Official Title  ICMJE A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE)
Brief Summary The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: NOMAC-E2

    Nomegestrol Acetate and Estradiol Tablets, 2.5 mg

    NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).

    Other Name: SCH 900121
  • Drug: DRSP-EE
    Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
    Other Name: SCH 900121
Study Arms  ICMJE
  • Experimental: NOMAC-E2

    Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2

    monophasic combined oral contraceptive

    Intervention: Drug: NOMAC-E2
  • Active Comparator: DRSP-EE
    Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive
    Intervention: Drug: DRSP-EE
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2008)
2152
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2007)
2080
Actual Study Completion Date  ICMJE April 1, 2008
Actual Primary Completion Date April 1, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sexually active women, at risk for pregnancy and not planning to use condoms.
  • Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles).
  • At least 18 but not older than 50 years of age at the time of screening.
  • Body mass index (BMI) of >/= 17 and </= 35.
  • Good physical and mental health.
  • Willing to give informed consent in writing.

Exclusion Criteria:

  • Contraindications for contraceptive steroids.
  • In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional

contraindications related to the antimineralocorticoid activity of drospirenone

(conditions that predispose to hyperkalemia):

  • Renal insufficiency
  • Hepatic dysfunction
  • Adrenal insufficiency
  • An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN],

Squamous Intraepithelial Lesion [SIL], carcinoma in situ, invasive carcinoma) at screening.

  • Clinically relevant abnormal laboratory result at screening as judged by the investigator.
  • Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration.
  • Before spontaneous menstruation has occurred following a delivery or abortion.
  • Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.
  • Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort).
  • Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Belgium,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Malaysia,   Netherlands,   Norway,   Poland,   Spain,   Sweden,   Switzerland,   Thailand,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00511199
Other Study ID Numbers  ICMJE P05724
Organon Protocol No. 292001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP