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

Primary Purpose

Uterine Fibroids and Heavy Menstrual Bleeding

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Vilaprisan (BAY1002670)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids and Heavy Menstrual Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Meitetsu Hospital
  • Kano's Clinic for Women
  • Kyoritsu Narashinodai Hospital
  • Aso Iizuka Hospital
  • Jusendo Geneal Hospital Yuasa Foundation
  • Sato Hospital
  • Hashimoto Clinic
  • Yoshio Clinic
  • Asahi-Clinic.
  • Kurashiki Medical Clinic
  • Medical Topia Soka Hospital
  • Sei Womens Clinic
  • St.Luke's International Hospital
  • Akazawa Clinic
  • Yokokura Clinic
  • Toranomon Womens Clinic
  • Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
  • Tokyo Women's Medical University Hospital
  • Kato Internal medicine and Gynecology Clinic
  • Hamanomachi Hospital
  • Medical corporation keizukai Chayamachi Ladies Clinic
  • Medical Corporation Koshinkai Nomura Clinic Namba
  • Izuma Clinic
  • Shizuoka Saiseikai General Hospital
  • Toyama Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Group A1

Treatment Group A2

Arm Description

4 treatment periods of 12 weeks, each separated by 1 bleeding episode

2 treatment periods of 24 weeks, separated by 2 bleeding episodes

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse event

Secondary Outcome Measures

Number of bleeding days

Full Information

First Posted
March 20, 2018
Last Updated
July 6, 2022
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03476928
Brief Title
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Acronym
ASTEROID 8
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to a change in the development program, the study was closed prematurely.
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
July 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids and Heavy Menstrual Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A1
Arm Type
Experimental
Arm Description
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
Arm Title
Treatment Group A2
Arm Type
Experimental
Arm Description
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2mg, once daily, oral
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse event
Time Frame
Up to one year and 3 months
Secondary Outcome Measure Information:
Title
Number of bleeding days
Time Frame
Up to one year and 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Meitetsu Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
451-8511
Country
Japan
Facility Name
Kano's Clinic for Women
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0011
Country
Japan
Facility Name
Kyoritsu Narashinodai Hospital
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
274-0063
Country
Japan
Facility Name
Aso Iizuka Hospital
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Jusendo Geneal Hospital Yuasa Foundation
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8585
Country
Japan
Facility Name
Sato Hospital
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0836
Country
Japan
Facility Name
Hashimoto Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0052
Country
Japan
Facility Name
Yoshio Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0808
Country
Japan
Facility Name
Asahi-Clinic.
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-0076
Country
Japan
Facility Name
Kurashiki Medical Clinic
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-0824
Country
Japan
Facility Name
Medical Topia Soka Hospital
City
Soka
State/Province
Saitama
ZIP/Postal Code
340-0028
Country
Japan
Facility Name
Sei Womens Clinic
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
112-0014
Country
Japan
Facility Name
St.Luke's International Hospital
City
Chuoku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Akazawa Clinic
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-0056
Country
Japan
Facility Name
Yokokura Clinic
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Toranomon Womens Clinic
City
Minato
State/Province
Tokyo
ZIP/Postal Code
105-0001
Country
Japan
Facility Name
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
City
Minato
State/Province
Tokyo
ZIP/Postal Code
107-0051
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Kato Internal medicine and Gynecology Clinic
City
Fukui
ZIP/Postal Code
910-0845
Country
Japan
Facility Name
Hamanomachi Hospital
City
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
Medical corporation keizukai Chayamachi Ladies Clinic
City
Osaka
ZIP/Postal Code
530-0013
Country
Japan
Facility Name
Medical Corporation Koshinkai Nomura Clinic Namba
City
Osaka
ZIP/Postal Code
542-0076
Country
Japan
Facility Name
Izuma Clinic
City
Osaka
ZIP/Postal Code
543-0023
Country
Japan
Facility Name
Shizuoka Saiseikai General Hospital
City
Shizuoka
ZIP/Postal Code
422-8527
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products

Learn more about this trial

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

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