Assess safety and efficacy of vilaprisan in subjects with uterine fibroids

• Register: EUCTR
• Last refreshed on: 4 January 2022
• Main ID: EUCTR2016-004822-41-FI
• Date of registration: 15/05/2017
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: Assess safety and efficacy of vilaprisan in subjects with uterine fibroids
• Scientific title: An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care - ASTEROID 6: Assess safety and efficacy of BAY1002670 in subjects with uterine fibroids
• Date of first enrolment: 23/05/2017
• Target sample size: 1302
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004822-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: nonhormonal standard of care; Number of treatment arms in the trial: 8
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

China, Colombia, Czech Republic, Finland, Hong Kong, Japan, Mexico, Norway, Poland, Russian Federation, South Africa, Spain, Thailand, Turkey, United States

Contacts

• Name: Bayer Clinical Trial Contact
• Affiliation: Bayer AG

• Name: Bayer Clinical Trial Contact
• Affiliation: Bayer AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed and dated informed consent
2. 18 years or older
3.Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
4. At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
5. Good general health
6. Normal or clinically insignificant cervical smear
7. An endometrial biopsy performed during the screening period, without significant histological disorder
8.Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study

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 1302
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
2. Hypersensitivity to any ingredient of the study drug
3. Any condition requiring immediate blood transfusion
4. 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
5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
6. Abuse of alcohol, drugs, or medicines (eg, laxatives)
7. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
8. Undiagnosed abnormal genital bleeding



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

Health Condition(s) or Problem(s) studied

Women, 18 years or older, diagnosis of uterine fibroid(s) documented by ultrasound at screening and/or during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence, at least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain, good general health, normal or clinically insignificant cervical smear and an endometrial biopsy performed during the screening period without significant histologic disorder
MedDRA version: 21.1 Level: LLT Classification code 10016628 Term: Fibroids 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 2 mg 245
Product Code: BAY 1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
CAS Number: 1262108-14-4
Current Sponsor code: BAY 1002670
Other descriptive name: BAY 1002670 micronized
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Primary end point(s): Percentage of change in bone mineral density (BMD) of lumbar spine

Secondary Objective: The secondary objective of this study is to evaluate the efficacy of vilaprisan in subjects with uterine fibroids in comparison to nonhormonal medical treatment in accordance with local standard of care.

Main Objective: The primary objective of this study is to evaluate the safety of vilaprisan in subjects with uterine fibroids in comparison to nonhormonal medical treatment in accordance with local standard of care

Timepoint(s) of evaluation of this end point: one year

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Approximately 1 year for subgroup 1 and approximately 2 years for subgroup 2

Secondary end point(s): Number of bleeding days

Secondary ID(s)

BAY1002670/16953

2016-004822-41-CZ

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date: 23/05/2017
Contact: