Clinical Trials List
2017-09-21 - 2021-10-14
Phase III
Terminated8
ICD-10D25.9
Leiomyoma of uterus, unspecified
A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
Bayer AG.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 蔡青倍 Division of Obstetrics & Gynecology
- YU-CHIAO YI Division of Obstetrics & Gynecology
- 吳振豪 Division of Radiology
- Chien-Hsing Lu Division of Obstetrics & Gynecology
- 孫珞 Division of Obstetrics & Gynecology
- 許世典 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Huei-Jean Huang Division of Obstetrics & Gynecology
- 黃于庭 Division of Radiology
- Angel Chao Division of Obstetrics & Gynecology
- Gigin Lin Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 何彥秉 Division of Obstetrics & Gynecology
- Pei-Chen Huang Division of Obstetrics & Gynecology
- 王美衡 Division of Obstetrics & Gynecology
- Wei-Chun Chang Division of Obstetrics & Gynecology
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
- Chi-Hong Ho Division of Obstetrics & Gynecology
- Huann-Cheng Horng Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 郭昱伶 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- YI-HUA LIAO 無
- 張文君 Division of Obstetrics & Gynecology
- 施怡倫 Division of Radiology
- CHU-CHUN HUANG Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days.
For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.
Inclution Criteria
Women, 18 years or older at the time of Visit 1
Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
Use of an acceptable non-hormonal method of contraception
An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
Exclusion Criteria
Hypersensitivity to any ingredient of the study drugs
Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
Any diseases, conditions, or medications 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
Abuse of alcohol, drugs, or medicines (eg: laxatives)
Undiagnosed abnormal genital bleeding
Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
The Estimated Number of Participants
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Taiwan
52 participants
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Global
716 participants
