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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 28, 2012
Last updated: February 16, 2016
Last verified: January 2016

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.

Condition Intervention Phase
Drug: EE20/DRSP(BAY86-5300)
Drug: Placebo
Drug: Dienogest
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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.

Enrollment: 312
Study Start Date: October 2012
Study Completion Date: December 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01697111

Anjo, Aichi, Japan, 446-8510
Ichinomiya, Aichi, Japan, 491-8551
Nagoya, Aichi, Japan, 451-8511
Nagoya, Aichi, Japan, 460-0011
Nagoya, Aichi, Japan, 464-0066
Matsudo, Chiba, Japan, 270-2267
Takasaki, Gunma, Japan, 370-0883
Itami, Hyogo, Japan, 664-8540
Kawanishi, Hyogo, Japan, 666-0125
Kobe, Hyogo, Japan, 654-0047
Kanazawa, Ishikawa, Japan, 920-8530
Kamakura, Kanagawa, Japan, 247-8533
Kawasaki, Kanagawa, Japan, 212-0016
Yokohama, Kanagawa, Japan, 230-0001
Yokohama, Kanagawa, Japan, 231-0023
Toyonaka, Osaka, Japan, 560-0022
Kitamoto, Saitama, Japan, 364-8501
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
Fukui, Japan, 910-0845
Fukui, Japan, 910-8526
Gifu, Japan, 500-8717
Osaka, Japan, 530-0001
Osaka, Japan, 530-0013
Osaka, Japan, 542-0086
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01697111     History of Changes
Other Study ID Numbers: 15457
Study First Received: September 28, 2012
Last Updated: February 16, 2016

Keywords provided by Bayer:
Flexible regimen
Ethinylestradiol Betadex
Japanese Patients

Additional relevant MeSH terms:
Genital Diseases, Female
Ethinyl Estradiol
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral
Contraceptive Agents, Female
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on May 24, 2017