A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding (ASTEROID 8)

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

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

Study Overview

• Status: Terminated
• Conditions: Uterine Fibroids and Heavy Menstrual Bleeding
• Intervention / Treatment: Drug: Vilaprisan (BAY1002670)

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukui, Japan, 910-0845
    • Kato Internal medicine and Gynecology Clinic
  • Fukuoka, Japan, 810-8539
    • Hamanomachi Hospital
  • Osaka, Japan, 530-0013
    • Medical corporation keizukai Chayamachi Ladies Clinic
  • Osaka, Japan, 542-0076
    • Medical Corporation Koshinkai Nomura Clinic Namba
  • Osaka, Japan, 543-0023
    • Izuma Clinic
  • Shizuoka, Japan, 422-8527
    • Shizuoka Saiseikai General Hospital
  • Toyama, Japan, 930-8550
    • Toyama Prefectural Central Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 451-8511
      • Meitetsu Hospital
    • Nagoya, Aichi, Japan, 460-0011
      • Kano's Clinic for Women
  • Chiba
    • Funabashi, Chiba, Japan, 274-0063
      • Kyoritsu Narashinodai Hospital
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8505
      • Aso Iizuka Hospital
  • Fukushima
    • Koriyama, Fukushima, Japan, 963-8585
      • Jusendo Geneal Hospital Yuasa Foundation
  • Gunma
    • Takasaki, Gunma, Japan, 370-0836
      • Sato Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 004-0052
      • Hashimoto Clinic
    • Sapporo, Hokkaido, Japan, 064-0808
      • Yoshio Clinic
  • Kagawa
    • Takamatsu, Kagawa, Japan, 760-0076
      • Asahi-Clinic.
  • Okayama
    • Kurashiki, Okayama, Japan, 710-0824
      • Kurashiki Medical Clinic
  • Saitama
    • Soka, Saitama, Japan, 340-0028
      • Medical Topia Soka Hospital
  • Tokyo
    • Bunkyo, Tokyo, Japan, 112-0014
      • Sei Womens Clinic
    • Chuoku, Tokyo, Japan, 104-8560
      • St.Luke's International Hospital
    • Fuchu, Tokyo, Japan, 183-0056
      • Akazawa Clinic
    • Minato, Tokyo, Japan, 105-0001
      • Toranomon Womens Clinic
    • Minato, Tokyo, Japan, 107-0051
      • Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
    • Minato-ku, Tokyo, Japan, 108-0014
      • Yokokura Clinic
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group A1; 4 treatment periods of 12 weeks, each separated by 1 bleeding episode	Drug: Vilaprisan (BAY1002670); 2mg, once daily, oral
Experimental: Treatment Group A2; 2 treatment periods of 24 weeks, separated by 2 bleeding episodes	Drug: Vilaprisan (BAY1002670); 2mg, once daily, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse event	Up to one year and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of bleeding days	Up to one year and 3 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Hemorrhage; Leiomyoma; Myofibroma; Menorrhagia
• Other Study ID Numbers: 19435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No