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Trial record 24 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT01892904
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE July 2, 2013
First Posted Date  ICMJE July 8, 2013
Last Update Posted Date September 9, 2015
Study Start Date  ICMJE July 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Number of days with dysmenorrheic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01892904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • Change in Dysmenorrhea score from baseline to period of withdrawal bleeding [ Time Frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit
  • Change of severity of pain Description [ Time Frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.
  • Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.
  • Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Number of days with rescue medicine is determined based on daily record of Patient Diary.
  • Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period [ Time Frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days ]
    Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary
  • Endometrial thickness [ Time Frame: 24 weeks after taking the initial study medication ]
    Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.
  • Number of days with bleeding and spotting over treatment phase [ Time Frame: Up to 24 weeks ]
    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea
Official Title  ICMJE A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks
Brief Summary

The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period).

The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation period.

In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients treated for one year will be investigated.

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: Treatment
Condition  ICMJE Dysmenorrhea
Intervention  ICMJE Drug: EE20/DRSP(BAY86-5300)
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
Study Arms  ICMJE
  • Experimental: EE20/DRSP(BAY86-5300)-flexibel extended regimen
    One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with flexible extended regimen (24-day to 120-day active tablet intake followed by 4-day tablet free interval)
    Intervention: Drug: EE20/DRSP(BAY86-5300)
  • Active Comparator: EE20/DRSP(BAY86-5300)-28 days cyclic regimen
    One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day with 28-day cyclic regimen (24-day active tablet intake followed by 4-day placebo tablet intake)
    Intervention: Drug: EE20/DRSP(BAY86-5300)
Publications * Not Provided

*   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: July 23, 2014)
216
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
204
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: - Dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase)

  • Patients with dysmenorrheic pain during the 2 baseline cycles before randomization. Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with possible radiation towards back or thighs recorded in the Patient Diary in correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start up to 2 days before the onset of the bleeding episode the bleeding and terminates on the last day of bleeding of before
  • Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
  • Willingness to use a barrier method (i.e., non-hormonal method) for contraception during the study. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device.

Exclusion Criteria: - Patients who have organic diseases of which surgical treatment is prioritized by the investigator

  • Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in size of the longest diameters
  • Patients with ovarian chocolate cysts having solid part in the cyst
  • Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01892904
Other Study ID Numbers  ICMJE 16114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2015

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