Trial Condition(s):
Endometriosis
Comparative study of BAY86-5300 with an extended flexible regimen for endometriosis
Bayer Identifier:
15457
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Yazaki Clinic Takasaki, Japan, 370-0883 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kitasato University Medeical Center Kitamoto, Japan, 364-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kusunoki Clinic Itabashi, Japan, 175-0092 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Wellness Ginza Clinic Chuo-ku, Japan, 104-0061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yukawa Women's Clinic Nishitokyo, Japan, 188-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Machida Higashiguchi Clinic Machida, Japan, 194-0022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akasakamitsuke Miyazaki Obstetrics & Gynecology Clinic Minato, Japan, 107-0051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NS Clinic Hachioji, Japan, 192-0046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-8533 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Corporation Eikoukai Yakou Lady's Clinic Yokohama, Japan, 230-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meitetsu Hospital Nagoya, Japan, 451-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Daiyukai Daiichi Hospital Ichinomiya, Japan, 491-8551 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yachiyo Hospital Anjo, Japan, 446-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sakie Ladies Clinic Nagoya, Japan, 464-0066 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kano's Clinic for Women Nagoya, Japan, 460-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gifu Prefectural General Medical Center Gifu, Japan, 500-8717 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ishikawa Prefectural Central Hospital Kanazawa, Japan, 920-8530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fukui Prefectural Hospital Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Katou Internal medicine and Gynecology Clinic Fukui, Japan, 910-0845 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yoshimura Ladies Clinic Toyonaka, Japan, 560-0022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Central Hospital Osaka, Japan, 530-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Veritas Hospital Kawanishi, Japan, 666-0125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinsuma Hospital Kobe, Japan, 654-0047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kawasaki Saiwai Clinic Kawasaki, Japan, 212-0016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Itami City Hospital Itami, Japan, 664-8540 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sei Womens Clinic Bunkyo, Japan, 112-0014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akazawa Clinic Fuchu, Japan, 183-0056 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Toranomon Womens Clinic Minato, Japan, 105-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Juno Vesta Clinic Hatta Matsudo, Japan, 270-2267 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Motomachi Ladies Clinic Yokohama, Japan, 231-0023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hayakawa Clinic Osaka, Japan, 542-0086 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chayamachi Ladies Clinic Osaka, Japan, 530-0013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Wellness Tsushima Ruriko Josei Life Clinic Chuo-ku, Japan, 104-0061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Change of pelvic pain from baseline period (8 weeks before start of treatment) to 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)Timeframe: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)
Secondary Outcome
- Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)Pelvic pain is the worst pain on a 0-10 scale rated by the participant.Timeframe: Weeks 17-24 of treatment period
- Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)Pelvic pain is the worst pain on a 0-10 scale rated by the participant.Timeframe: Weeks 17-24 of treatment period
- DyspareuniaIn case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.Timeframe: Weeks 17-24 of treatment period
- Average of painThe 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.Timeframe: Weeks 17-24 of treatment period
- Size of chocolate cystIn 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.Timeframe: 24 weeks after taking the initial study medication
- Endometrial thicknessEndometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.Timeframe: 24 weeks after taking the initial study medication
- Number of days with spotting/bleedingNumber of days with spotting/bleeding is determined based on daily record of Patient Diary.Timeframe: Up to 52 weeks
Additional Information
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