stop_circleTerminated/Withdrawn

Uterine fibroids and Heavy menstrual bleeding

Bayer Identifier:

19435

ClinicalTrials.gov Identifier:

NCT03476928

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to assess the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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
  • - 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
March 2018 - July 2021
Phase
Phase 3
Could I Receive a placebo
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hashimoto ClinicSapporo, 004-0052, Japan
Completed
Yoshio ClinicSapporo, 064-0808, Japan
Completed
Medical corporation keizukai Chayamachi Ladies ClinicOsaka, 530-0013, Japan
Completed
Kurashiki Medical ClinicKurashiki, 710-0824, Japan
Completed
Aso Iizuka HospitalIizuka, 820-8505, Japan
Completed
Medical Corporation Koshinkai Nomura Clinic NambaOsaka, 542-0076, Japan
Completed
Medical Topia Soka HospitalSoka, 340-0028, Japan
Completed
Sei Womens ClinicBunkyo, 112-0014, Japan
Completed
Yokokura ClinicMinato-ku, 108-0014, Japan
Completed
Kato Internal medicine and Gynecology ClinicFukui, 910-0845, Japan
Completed
Sato HospitalTakasaki, 370-0836, Japan
Completed
Hamanomachi HospitalFukuoka, 810-8539, Japan
Completed
IZUMA CLINICOsaka, 543-0023, Japan
Completed
Kano's Clinic for WomenNagoya, 460-0011, Japan
Active, not recruiting
Toranomon Womens ClinicMinato, 105-0001, Japan
Completed
Akasakamitsuke Miyazaki Obstetrics and Gynecology ClinicMinato, 107-0051, Japan
Completed
Toyama Prefectural Central HospitalToyama, 930-8550, Japan
Completed
Jusendo Geneal Hospital Yuasa FoundationKoriyama, 963-8585, Japan
Completed
Akazawa ClinicFuchu, 183-0056, Japan
Completed
Kyoritsu Narashinodai HospitalFunabashi, 274-0063, Japan
Completed
Shizuoka Saiseikai General HospitalShizuoka, 422-8527, Japan
Completed
Tokyo Women's Medical University HospitalShinjuku-ku, 162-8666, Japan
Completed
Asahi-Clinic.Takamatsu, 760-0076, Japan
Completed
Meitetsu HospitalNagoya, 451-8511, Japan
Withdrawn
Kamoi Women General ClinicYokohama, 224-0053, Japan
Active, not recruiting
St.Luke's International HospitalChuoku, 104-8560, Japan

Primary Outcome

  • Incidence of treatment-emergent adverse event
    date_rangeTime Frame:
    Up to one year and 3 months

Secondary Outcome

  • Number of bleeding days
    date_rangeTime Frame:
    Up to one year and 3 months

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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