Trial Condition(s):

Endometriosis

Comparative study of BAY86-5300 with an extended flexible regimen for endometriosis

Bayer Identifier:

15457

ClinicalTrials.gov Identifier:

NCT01697111

EudraCT Number:

Not Available

Study Completed

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
312
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Yazaki Clinic

Takasaki, Japan, 370-0883

Status
Completed
 
Locations

Kitasato University Medeical Center

Kitamoto, Japan, 364-8501

Status
Completed
 
Locations

Kusunoki Clinic

Itabashi, Japan, 175-0092

Status
Completed
 
Locations

Women's Wellness Ginza Clinic

Chuo-ku, Japan, 104-0061

Status
Terminated
 
Locations

Yukawa Women's Clinic

Nishitokyo, Japan, 188-0011

Status
Completed
 
Locations

Machida Higashiguchi Clinic

Machida, Japan, 194-0022

Status
Completed
 
Locations

Akasakamitsuke Miyazaki Obstetrics & Gynecology Clinic

Minato, Japan, 107-0051

Status
Completed
 
Locations

NS Clinic

Hachioji, Japan, 192-0046

Status
Completed
 
Locations

Shonan Kamakura General Hospital

Kamakura, Japan, 247-8533

Status
Completed
 
Locations

Medical Corporation Eikoukai Yakou Lady's Clinic

Yokohama, Japan, 230-0001

Status
Completed
 
Locations

Meitetsu Hospital

Nagoya, Japan, 451-8511

Status
Completed
 
Locations

Daiyukai Daiichi Hospital

Ichinomiya, Japan, 491-8551

Status
Completed
 
Locations

Yachiyo Hospital

Anjo, Japan, 446-8510

Status
Completed
 
Locations

Sakie Ladies Clinic

Nagoya, Japan, 464-0066

Status
Completed
 
Locations

Kano's Clinic for Women

Nagoya, Japan, 460-0011

Status
Completed
 
Locations

Gifu Prefectural General Medical Center

Gifu, Japan, 500-8717

Status
Completed
 
Locations

Ishikawa Prefectural Central Hospital

Kanazawa, Japan, 920-8530

Status
Completed
 
Locations

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

Status
Completed
 
Locations

Katou Internal medicine and Gynecology Clinic

Fukui, Japan, 910-0845

Status
Completed
 
Locations

Yoshimura Ladies Clinic

Toyonaka, Japan, 560-0022

Status
Completed
 
Locations

Osaka Central Hospital

Osaka, Japan, 530-0001

Status
Completed
 
Locations

The Veritas Hospital

Kawanishi, Japan, 666-0125

Status
Completed
 
Locations

Shinsuma Hospital

Kobe, Japan, 654-0047

Status
Completed
 
Locations

Kawasaki Saiwai Clinic

Kawasaki, Japan, 212-0016

Status
Completed
 
Locations

Itami City Hospital

Itami, Japan, 664-8540

Status
Completed
 
Locations

Sei Womens Clinic

Bunkyo, Japan, 112-0014

Status
Completed
 
Locations

Akazawa Clinic

Fuchu, Japan, 183-0056

Status
Completed
 
Locations

Toranomon Womens Clinic

Minato, Japan, 105-0001

Status
Completed
 
Locations

Juno Vesta Clinic Hatta

Matsudo, Japan, 270-2267

Status
Completed
 
Locations

Motomachi Ladies Clinic

Yokohama, Japan, 231-0023

Status
Completed
 
Locations

Hayakawa Clinic

Osaka, Japan, 542-0086

Status
Completed
 
Locations

Chayamachi Ladies Clinic

Osaka, Japan, 530-0013

Status
Completed
 
Locations

Women's Wellness Tsushima Ruriko Josei Life Clinic

Chuo-ku, Japan, 104-0061

Status
Completed
 

Trial Design