Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Trial, Phase I

Treatments: Drug: Vilaprisan (BAY1002670)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262663

15818

2014-000329-19 (EudraCT Number)

Details and patient eligibility

About

This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
• Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
• Pre-treatment cycle assessed as ovulatory and not longer than 44 days

Exclusion criteria

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
• Known or suspected liver disorders
• Amenorrhea for more than 3 months within the last 6 months before the first screening examination
• Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
• Positive urine pregnancy test
• Regular use of medicines

Trial design

70 participants in 4 patient groups

Vilaprisan [0.5mg]

Experimental group

Description:

0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Treatment:

Drug: Vilaprisan (BAY1002670)

Vilaprisan [1mg]

Experimental group

Description:

1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Treatment:

Drug: Vilaprisan (BAY1002670)

Vilaprisan [2mg]

Experimental group

Description:

2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Treatment:

Drug: Vilaprisan (BAY1002670)

Vilaprisan [4mg]

Experimental group

Description:

4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Treatment:

Drug: Vilaprisan (BAY1002670)