Trial Condition(s):

Uterine fibroids and Heavy menstrual bleeding

A study to assess the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (ASTEROID 8)

Bayer Identifier:

19435

ClinicalTrials.gov Identifier:

NCT03476928

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).

Inclusion Criteria
- 18 years or older
- Diagnosis of uterine fibroid(s) documented by ultrasound at screening
- Heavy menstrual bleeding (HMB) >80.00 mL associated with uterine fibroid(s)
- Good general health
- Normal or clinically insignificant cervical smear
- An endometrial biopsy performed during the screening period, without significant histological disorder
- Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
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 drug
- Any condition requiring immediate blood transfusion
- 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
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Abuse of alcohol, drugs, or medicines (e.g., laxatives)
- Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- Undiagnosed abnormal genital bleeding

Trial Summary

Enrollment Goal
153
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hashimoto Clinic

Sapporo, Japan, 004-0052

Status
Completed
 
Locations

Yoshio Clinic

Sapporo, Japan, 064-0808

Status
Completed
 
Locations

Medical corporation keizukai Chayamachi Ladies Clinic

Osaka, Japan, 530-0013

Status
Completed
 
Locations

Kurashiki Medical Clinic

Kurashiki, Japan, 710-0824

Status
Completed
 
Locations

Aso Iizuka Hospital

Iizuka, Japan, 820-8505

Status
Completed
 
Locations

Medical Corporation Koshinkai Nomura Clinic Namba

Osaka, Japan, 542-0076

Status
Completed
 
Locations

Medical Topia Soka Hospital

Soka, Japan, 340-0028

Status
Completed
 
Locations

Sei Womens Clinic

Bunkyo, Japan, 112-0014

Status
Completed
 
Locations

Yokokura Clinic

Minato-ku, Japan, 108-0014

Status
Completed
 
Locations

Kato Internal medicine and Gynecology Clinic

Fukui, Japan, 910-0845

Status
Completed
 
Locations

Sato Hospital

Takasaki, Japan, 370-0836

Status
Completed
 
Locations

Hamanomachi Hospital

Fukuoka, Japan, 810-8539

Status
Completed
 
Locations

IZUMA CLINIC

Osaka, Japan, 543-0023

Status
Completed
 
Locations

Kano's Clinic for Women

Nagoya, Japan, 460-0011

Status
Completed
 
Locations

Toranomon Womens Clinic

Minato, Japan, 105-0001

Status
Active, not recruiting
 
Locations

Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic

Minato, Japan, 107-0051

Status
Completed
 
Locations

Toyama Prefectural Central Hospital

Toyama, Japan, 930-8550

Status
Completed
 
Locations

Jusendo Geneal Hospital Yuasa Foundation

Koriyama, Japan, 963-8585

Status
Completed
 
Locations

Akazawa Clinic

Fuchu, Japan, 183-0056

Status
Completed
 
Locations

Kyoritsu Narashinodai Hospital

Funabashi, Japan, 274-0063

Status
Completed
 
Locations

Shizuoka Saiseikai General Hospital

Shizuoka, Japan, 422-8527

Status
Completed
 
Locations

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Asahi-Clinic.

Takamatsu, Japan, 760-0076

Status
Completed
 
Locations

Meitetsu Hospital

Nagoya, Japan, 451-8511

Status
Completed
 
Locations

St.Luke's International Hospital

Chuoku, Japan, 104-8560

Status
Active, not recruiting
 

Trial Design