Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis
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ClinicalTrials.gov Identifier: NCT01697111 |
Recruitment Status :
Completed
First Posted : October 2, 2012
Last Update Posted : February 18, 2016
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis | Drug: EE20/DRSP(BAY86-5300) Drug: Placebo Drug: Dienogest | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 312 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | December 2014 |

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) |
- 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)
- 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697111
Japan | |
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 |
Study Director: | Bayer Study Director | Bayer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01697111 |
Other Study ID Numbers: |
15457 |
First Posted: | October 2, 2012 Key Record Dates |
Last Update Posted: | February 18, 2016 |
Last Verified: | January 2016 |
YAZ Flexible regimen Drospirenone Ethinylestradiol Betadex |
Endometriosis Dienogest Japanese Patients |
Endometriosis Dienogest Contraceptive Agents, Male Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Contraceptives, Oral Contraceptive Agents, Female Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |