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

February 16, 2016 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukui, Japan, 910-8526
      • Fukui, Japan, 910-0845
      • Gifu, Japan, 500-8717
      • Osaka, Japan, 530-0001
      • Osaka, Japan, 530-0013
      • Osaka, Japan, 542-0086
    • Aichi
      • Anjo, Aichi, Japan, 446-8510
      • Ichinomiya, Aichi, Japan, 491-8551
      • Nagoya, Aichi, Japan, 460-0011
      • Nagoya, Aichi, Japan, 464-0066
      • Nagoya, Aichi, Japan, 451-8511
    • Chiba
      • Matsudo, Chiba, Japan, 270-2267
    • Gunma
      • Takasaki, Gunma, Japan, 370-0883
    • Hyogo
      • Itami, Hyogo, Japan, 664-8540
      • Kawanishi, Hyogo, Japan, 666-0125
      • Kobe, Hyogo, Japan, 654-0047
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8530
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-8533
      • Kawasaki, Kanagawa, Japan, 212-0016
      • Yokohama, Kanagawa, Japan, 230-0001
      • Yokohama, Kanagawa, Japan, 231-0023
    • Osaka
      • Toyonaka, Osaka, Japan, 560-0022
    • Saitama
      • Kitamoto, Saitama, Japan, 364-8501
    • Tokyo
      • Bunkyo, Tokyo, Japan, 112-0014
      • Chuo-ku, Tokyo, Japan, 104-0061
      • Fuchu, Tokyo, Japan, 183-0056
      • Hachioji, Tokyo, Japan, 192-0046
      • Itabashi, Tokyo, Japan, 175-0092
      • Machida, Tokyo, Japan, 194-0022
      • Minato, Tokyo, Japan, 105-0001
      • Minato, Tokyo, Japan, 107-0051
      • Nishitokyo, Tokyo, Japan, 188-0011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: EE20/DRSP(BAY86-5300)
One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
EXPERIMENTAL: Arm 2
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
ACTIVE_COMPARATOR: Arm 3
Drug: Dienogest
Dienogest 1mg twice a day (bid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks after taking the initial study medication
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.
Weeks 17-24 of treatment period
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.
Weeks 17-24 of treatment period
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.
Weeks 17-24 of treatment period
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.
Weeks 17-24 of treatment period
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.
24 weeks after taking the initial study medication
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.
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (ESTIMATE)

October 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15457

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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