Clinical trial NCT03476928: A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Official title: An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids and Heavy Menstrual Bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-03-26
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse event
timeFrame: Up to one year and 3 months
Secondary outcomes:
measure: Number of bleeding days
timeFrame: Up to one year and 3 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Meitetsu Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Kano's Clinic for Women
state: Aichi
city: Funabashi
country: Japan
facility: Kyoritsu Narashinodai Hospital
state: Chiba
city: Iizuka
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Jusendo Geneal Hospital Yuasa Foundation
state: Fukushima
city: Takasaki
country: Japan
facility: Sato Hospital
state: Gunma
city: Sapporo
country: Japan
facility: Hashimoto Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Yoshio Clinic
state: Hokkaido
city: Takamatsu
country: Japan
facility: Asahi-Clinic.
state: Kagawa
city: Kurashiki
country: Japan
facility: Kurashiki Medical Clinic
state: Okayama
city: Soka
country: Japan
facility: Medical Topia Soka Hospital
state: Saitama
city: Bunkyo
country: Japan
facility: Sei Womens Clinic
state: Tokyo
city: Chuoku
country: Japan
facility: St.Luke's International Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Akazawa Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: Yokokura Clinic
state: Tokyo
city: Minato
country: Japan
facility: Toranomon Womens Clinic
state: Tokyo
city: Minato
country: Japan
facility: Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Fukui
country: Japan
facility: Kato Internal medicine and Gynecology Clinic
city: Fukuoka
country: Japan
facility: Hamanomachi Hospital
city: Osaka
country: Japan
facility: Medical corporation keizukai Chayamachi Ladies Clinic
city: Osaka
country: Japan
facility: Medical Corporation Koshinkai Nomura Clinic Namba
city: Osaka
country: Japan
facility: Izuma Clinic
city: Shizuoka
country: Japan
facility: Shizuoka Saiseikai General Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
Study officials:
References: