Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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13 June 2016 |
Main ID: |
EUCTR2013-003945-40-BG |
Date of registration:
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27/05/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Assess safety and efficacy of BAY 1002670 in subjects with uterine fibroids
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Scientific title:
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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:
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14/08/2014 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003945-40 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Bulgaria
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Canada
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Czech Republic
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Finland
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Germany
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Hungary
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Japan
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Norway
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Spain
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Sweden
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United States
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Contacts
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Name:
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Bayer Clinical Trials Contract
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Address:
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Mullerstrasse 170-178
13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contract@bayerhealthcare.com |
Affiliation:
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Bayer HealthCare AG |
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Name:
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Bayer Clinical Trials Contract
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Address:
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Mullerstrasse 170-178
13342
Berlin
Germany |
Telephone:
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Email:
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clinical-trials-contract@bayerhealthcare.com |
Affiliation:
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Bayer HealthCare AG |
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Key inclusion & exclusion criteria
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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 40 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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
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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: 18.0
Level: LLT
Classification code 10046784
Term: Uterine fibroids
System Organ Class: 100000004864
MedDRA version: 18.0
Level: LLT
Classification code 10016628
Term: Fibroids
System Organ Class: 100000004864
MedDRA version: 18.0
Level: LLT
Classification code 10022794
Term: Intramural leiomyoma of uterus
System Organ Class: 100000004864
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Main Objective: To assess the dose-response relationship of BAY 1002670 in subjects with uterine fibroids.
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Timepoint(s) of evaluation of this end point: After end of the initial bleeding episode until the end of treatment
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Primary end point(s): Amenorrhea (yes/no)
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Secondary Outcome(s)
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Secondary end point(s): 1. Volume of menstrual blood loss per 28 days (assessed by AH method)
2. Time to onset of controlled bleeding
3. Percent change in volume of largest fibroid compared to baseline
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Timepoint(s) of evaluation of this end point: 1. during treatment and follow-up
2. during treatment
3. end of treatment versus baseline
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Secondary ID(s)
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BAY1002670/15788
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2013-003945-40-SE
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Source(s) of Monetary Support
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Bayer HealthCare AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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