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Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 7)

Primary Purpose

Uterine Fibroids

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Withdrawn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

About this trial

This is an interventional treatment trial for Uterine Fibroids

Eligibility Criteria

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

Inclusion Criteria:

  • Women, 18 years or older at the time of Visit 1
  • Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more)
  • Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the menstrual pictogram (MP)
  • Use of an acceptable non-hormonal method of contraception
  • An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology

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 drugs
  • Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
  • 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 including
  • Abuse of alcohol, drugs, or medicines (eg: laxatives)
  • Undiagnosed abnormal genital bleeding
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Sites / Locations

  • Funabashi Municipal Medical Center
  • Matsudo City General Hospital
  • Ena Odori Clinic
  • Tokeidai Memorial Clinic
  • Asahi clinic
  • Kagawa Prefectural Central Hospital
  • Unoki Clinic
  • Japanese Red Cross Kumamoto Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vilaprisan

Placebo

Arm Description

2 treatment periods of 12 weeks without a break

2 treatment periods of 12 weeks without a break

Outcomes

Primary Outcome Measures

Amenorrhea (yes/no)
Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)

Secondary Outcome Measures

Heavy menstrual bleeding (HMB) response (yes/no)
Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline
Time to onset of amenorrhea
Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2mL.
Time to onset of controlled bleeding
Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL.
Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)
Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)
Endometrial thickness

Full Information

First Posted
October 5, 2018
Last Updated
January 15, 2020
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03699176
Brief Title
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Acronym
ASTEROID 7
Official Title
A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No patient was recruited, study withdrawn for feasibility reasons.
Study Start Date
October 27, 2018 (Actual)
Primary Completion Date
December 25, 2019 (Actual)
Study Completion Date
December 25, 2019 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vilaprisan
Arm Type
Experimental
Arm Description
2 treatment periods of 12 weeks without a break
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 treatment periods of 12 weeks without a break
Intervention Type
Drug
Intervention Name(s)
Vilaprisan (BAY1002670)
Intervention Description
2 mg, once daily, oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily, oral
Primary Outcome Measure Information:
Title
Amenorrhea (yes/no)
Description
Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)
Time Frame
Up to 24 weeks (The last 28 days of treatment period 2)
Secondary Outcome Measure Information:
Title
Heavy menstrual bleeding (HMB) response (yes/no)
Description
Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline
Time Frame
Up to 24 weeks (the last 28 days of treatment period 2)
Title
Time to onset of amenorrhea
Description
Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2mL.
Time Frame
Up to 24 weeks
Title
Time to onset of controlled bleeding
Description
Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL.
Time Frame
Up to 24 weeks
Title
Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)
Time Frame
Up to 24 weeks (the last 28 days of treatment period 2)
Title
Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)
Time Frame
Up to 36 weeks
Title
Endometrial thickness
Time Frame
Up to 36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women, 18 years or older at the time of Visit 1 Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more) Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the menstrual pictogram (MP) Use of an acceptable non-hormonal method of contraception An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology 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 drugs Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation) 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 including Abuse of alcohol, drugs, or medicines (eg: laxatives) Undiagnosed abnormal genital bleeding Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
Facility Information:
Facility Name
Funabashi Municipal Medical Center
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
273-8588
Country
Japan
Facility Name
Matsudo City General Hospital
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2296
Country
Japan
Facility Name
Ena Odori Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Tokeidai Memorial Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0031
Country
Japan
Facility Name
Asahi clinic
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-0076
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Unoki Clinic
City
Kagoshima
ZIP/Postal Code
892-0826
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan

12. IPD Sharing Statement

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Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

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