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

Sponsor

Bayer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03699176

Collaborator

(none)

Enrollment

Locations

Arms

13.9

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Drug: Vilaprisan (BAY1002670) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 27, 2018

Actual Primary Completion Date :

Dec 25, 2019

Actual Study Completion Date :

Dec 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vilaprisan 2 treatment periods of 12 weeks without a break	Drug: Vilaprisan (BAY1002670) 2 mg, once daily, oral
Placebo Comparator: Placebo 2 treatment periods of 12 weeks without a break	Drug: Placebo Once daily, oral

Arm

Intervention/Treatment

Experimental: Vilaprisan

2 treatment periods of 12 weeks without a break

Drug: Vilaprisan (BAY1002670)

2 mg, once daily, oral

Placebo Comparator: Placebo

2 treatment periods of 12 weeks without a break

Drug: Placebo

Once daily, oral

Outcome Measures

Primary Outcome Measures

Amenorrhea (yes/no) [Up to 24 weeks (The last 28 days of treatment period 2)]
Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)

Secondary Outcome Measures

Heavy menstrual bleeding (HMB) response (yes/no) [Up to 24 weeks (the last 28 days of treatment period 2)]
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 [Up to 24 weeks]
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 [Up to 24 weeks]
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) [Up to 24 weeks (the last 28 days of treatment period 2)]
Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy) [Up to 36 weeks]
Endometrial thickness [Up to 36 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Funabashi Municipal Medical Center	Funabashi	Chiba	Japan	273-8588
2	Matsudo City General Hospital	Matsudo	Chiba	Japan	270-2296
3	Ena Odori Clinic	Sapporo	Hokkaido	Japan	060-0001
4	Tokeidai Memorial Clinic	Sapporo	Hokkaido	Japan	060-0031
5	Asahi clinic	Takamatsu	Kagawa	Japan	760-0076
6	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa	Japan	760-8557
7	Unoki Clinic	Kagoshima		Japan	892-0826
8	Japanese Red Cross Kumamoto Hospital	Kumamoto		Japan	861-8520

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT03699176

Other Study ID Numbers:

19434

First Posted:

Oct 9, 2018

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Jan 18, 2020