Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01697111
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 28, 2012
First Posted Date  ICMJE October 2, 2012
Last Update Posted Date February 18, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24) [ Time Frame: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24) ]
The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
  • Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain) [ Time Frame: Weeks 17-24 of treatment period ]
    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
  • Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain) [ Time Frame: Weeks 17-24 of treatment period ]
    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.
  • Dyspareunia [ Time Frame: Weeks 17-24 of treatment period ]
    In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.
  • Average of pain [ Time Frame: Weeks 17-24 of treatment period ]
    The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary.
  • Size of chocolate cyst [ Time Frame: 24 weeks after taking the initial study medication ]
    In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography.
  • 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 spotting/bleeding [ Time Frame: Up to 52 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 an Extended Flexible Regimen for Endometriosis
Official Title  ICMJE A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis
Brief Summary

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase.

The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.

The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: EE20/DRSP(BAY86-5300)
    One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
  • Drug: Placebo
    One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively
  • Drug: Dienogest
    Dienogest 1mg twice a day (bid)
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: EE20/DRSP(BAY86-5300)
  • Experimental: Arm 2
    Intervention: Drug: Placebo
  • Active Comparator: Arm 3
    Intervention: Drug: Dienogest
Publications * Harada T, Kosaka S, Elliesen J, Yasuda M, Ito M, Momoeda M. Ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial. Fertil Steril. 2017 Nov;108(5):798-805. doi: 10.1016/j.fertnstert.2017.07.1165. Epub 2017 Sep 11.

*   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: November 5, 2013)
312
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2012)
300
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by identification of chocolate cyst of endometriosis, or patients with the clinical diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or induration of Cul-de-sac or uterine immobility
  • Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase)
  • Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
  • Patients who do not wish to become pregnant during the course of the study

Exclusion Criteria:

  • Patients who have organic diseases of which surgical treatment is prioritized by investigator
  • Patients in whom any hormonal therapies, including combined oral contraceptives (COCs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain)
  • Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
  • Patients for whom dienogest is contraindicated (according to Japanese labeling of Dinagest Tab 1mg)
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 NCT01697111
Other Study ID Numbers  ICMJE 15457
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 January 2016

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