Assess safety and efficacy of BAY 1002670 in subjects with uterine fibroids

• Register: EUCTR
• Last refreshed on: 23 January 2017
• Main ID: EUCTR2013-003945-40-CZ
• Date of registration: 20/03/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: Assess safety and efficacy of BAY 1002670 in subjects with uterine fibroids
• Scientific title: A randomized, parallel-group, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of different doses of BAY 1002670 in subjects with uterine fibroids over 3 months - ASTEROID 1
• Date of first enrolment: 28/05/2014
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003945-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Canada, Czech Republic, Finland, Germany, Hungary, Japan, Norway, Spain, Sweden, United States

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed and dated informed consent
2. Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >=3.0 cm
3. 18 to 50 years of age at the time of screening
4. Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit
5. Normal or clinically insignificant cervical smear not requiring further follow-up
6. An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
7. Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
8. Good general health (except for findings related to uterine fibroids)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnancy or lactation
2. Uterine fibroid with largest diameter >10.0 cm
3. Hypersensitivity to any ingredient of the study drug
4. Laboratory values outside inclusion range before randomization and considered as clinically relevant
5. Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive iron supplementation)
6. Any diseases or conditions 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
7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
8. Abuse of alcohol, drugs, or medicines
9. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Women, 18 to 50 years old, with uterine fibroids documented by transvaginal or abdominal ultrasound at screening with at least 1 uterine fibroid with largest diameter >=3.0 cm and heavy menstrual bleeding >80 mL will be eligible for enrollment in the study.
MedDRA version: 19.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864
MedDRA version: 19.1 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864
MedDRA version: 19.1 Level: LLT Classification code 10022794 Term: Intramural leiomyoma of uterus System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Intervention(s)

Product Name: BAY 1002670 coated tablet 0.5 mg 242
Product Code: BAY1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
Current Sponsor code: BAY 1002670
Other descriptive name: BAY 1002670 micronized
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: BAY 1002670 coated tablet 1 mg 244
Product Code: BAY1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
Current Sponsor code: BAY 1002670
Other descriptive name: BAY 1002670 micronized
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: BAY 1002670 coated tablet 2 mg 245
Product Code: BAY1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
Current Sponsor code: BAY 1002670
Other descriptive name: BAY 1002670 micronized
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: BAY 1002670 coated tablet 4 mg 246
Product Code: BAY1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
Current Sponsor code: BAY 1002670
Other descriptive name: BAY 1002670 micronized
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To evaluate the safety of different doses of BAY 1002670 in subjects with uterine fibroids.
To establish a population pharmacokinetic/pharmacodynamic relationship for BAY 1002670 in subjects with uterine fibroids.
To assess the interchangeability of menstrual pictogram and alkaline hematin method for judgment of menstrual blood loss.

Main Objective: To assess the dose-response relationship of BAY 1002670 in subjects with uterine fibroids.

Timepoint(s) of evaluation of this end point: After end of the initial bleeding episode until the end of treatment

Primary end point(s): Amenorrhea (yes/no)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. during treatment and follow-up
2. during treatment
3. end of treatment versus baseline

Secondary end point(s): 1. Volume of menstrual blood loss per 28 days (assessed by Alkaline Hematin method)
2. Time to onset of controlled bleeding
3. Percent change in volume of largest fibroid compared to baseline

Secondary ID(s)

2013-003945-40-SE

BAY1002670/15788

Source(s) of Monetary Support

Bayer HealthCare AG