Trial Condition(s):

Uterine Fibroids

Assessment of safety and efficacy of vilaprisan in subjects with uterine fibroids (ASTEROID 7)

Bayer Identifier:

19434

ClinicalTrials.gov Identifier:

NCT03699176

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

Inclusion 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 of ≥ 30 mm  (alternatively, of 30 mm or more)
- Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the menstrual pictogram (MP)   
- 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
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) 
- 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

Trial Summary

Enrollment Goal
0
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Ena Odori Clinic

Sapporo, Japan, 060-0001

Status
Completed
 
Locations

Unoki Clinic

Kagoshima, Japan, 892-0826

Status
Completed
 
Locations

Tokeidai Memorial Clinic

Sapporo, Japan, 060-0031

Status
Completed
 
Locations

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan, 861-8520

Status
Completed
 
Locations

Asahi clinic

Takamatsu, Japan, 760-0076

Status
Completed
 
Locations

Matsudo City General Hospital

Matsudo, Japan, 270-2296

Status
Completed
 
Locations

Funabashi Municipal Medical Center

Funabashi, Japan, 273-8588

Status
Completed
 
Locations

Kagawa Prefectural Central Hospital

Takamatsu, Japan, 760-8557

Status
Completed
 

Trial Design