Assess safety and efficacy of vilaprisan in subjects with uterine fibroids

Phase 1

• Conditions: 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: 21.1Level: LLTClassification code 10016628Term: FibroidsSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-004822-41-CZ
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-28
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1302

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified