Clinical Trials List
2018-12-01 - 2021-08-31
Phase II
Not yet recruiting3
Terminated3
ICD-9617.9
Endometriosis, site unspecified
A Randomized, Double-blind, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Two Different Doses of Vilaprisan (BAY1002670) Versus Placebo in Women With Symptomatic Endometriosis
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
Bayer
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 張文君 Division of Obstetrics & Gynecology
- CHU-CHUN HUANG Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- YU-CHIAO YI Division of Obstetrics & Gynecology
- Chien-Hsing Lu Division of Obstetrics & Gynecology
- 許世典 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 鄭雅敏 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- CHU-CHUN HUANG Division of Obstetrics & Gynecology
- 張文君 Division of Obstetrics & Gynecology
- MEI-JOU CHEN Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Meng-Hsing Wu Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]).
Secondary Outcome Measures:
1. Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) on Days With/Without Vaginal Bleeding.
2. Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP).
3. Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP).
4. The Number of Participants With Treatment Emergent Adverse Events (TEAEs).
5. Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings.
6. Number of Participants With Clinical Significant Abnormal Ultrasound Examinations.
7. Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements.
8. Number of Participants With Clinical Significant Abnormal Laboratory Values.
Inclution Criteria
2. Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1.
3. Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging.
4. Moderate to severe endometriosis-associated pelvic pain (EAPP).
5. Adherence to screening period diary entries.
6. Willingness to use only standardized pain medication if needed.
7. Good general health (except for findings related to endometriosis).
8. Normal or clinically insignificant cervical cytology not requiring further follow-up.
9. An endometrial biopsy performed at the screening phase without significant. histological disorder.
10. Use of an acceptable non-hormonal method of contraception.
11. Willingness / ability to comply with electronic diary entry for the duration of study participation.
Exclusion Criteria
2. Hypersensitivity to any ingredient of the study treatments.
3. Laboratory values outside the inclusion range before randomization, and considered clinically relevant.
4. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including elevated liver enzymes.
5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results.
6. Undiagnosed abnormal genital bleeding.
7. Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator.
8. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results.
9. Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol.
10. Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator.
11. Inability to cooperate with the study procedures for any reason.
12. Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias).
13. Hypersensitivity to any ingredient of standardized pain medication.
14. Wish for pregnancy during the study.
15. Regular use of pain medication due to other underlying diseases.
16. Non-responsiveness of EAPP to GnRH-a (Gonadotropin-releasing hormone agonists).
The Estimated Number of Participants
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Taiwan
14 participants
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Global
315 participants
