Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 6)

Bayer

Status and phase: Active, not recruiting; Phase 3

Conditions: Uterine Fibroids

Treatments: Drug: Vilaprisan (BAY1002670); Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03194646

16953

2016-004822-41 (EudraCT Number)

Details and patient eligibility

About

The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Enrollment: 1,272 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• An endometrial biopsy performed during the screening period, without significant histological disorder
• Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study

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 drug
• Any condition requiring immediate blood transfusion
• 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
• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
• Abuse of alcohol, drugs, or medicines (eg, laxatives)
• Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
• Undiagnosed abnormal genital bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,272 participants in 4 patient groups

A1(3/1 regimen)

Experimental group

Description:

2.0 mg treatment of 12 weeks, each separated by 1 bleeding break

Treatment:

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

A2(6/2 regimen)

Experimental group

Description:

2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break

Treatment:

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

A3(3/2 regimen)

Experimental group

Description:

2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break

Treatment:

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

Drug: Vilaprisan (BAY1002670)

B(Standard of care)

Other group

Description:

Standard of care as determined by the investigators, this could be watch \& wait or non-hormonal medical treatment

Treatment:

Other: Standard of care