Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Trial ,Phase I

Treatments: Drug: Microgynon; Drug: Microgynon Placebo; Drug: Vilaprisan Placebo; Drug: Vilaprisan (BAY 1002670)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03210246

2016-004532-38 (EudraCT Number)

17670

Details and patient eligibility

About

This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.

Enrollment: 71 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female premenopausal subjects
• Age: 18 to 35 years (inclusive)
• Body mass index (BMI) : ≥18 and ≤30 kg/m²
• Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)

Exclusion criteria

• Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal
• presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups, including a placebo group

COC + Vilaprisan

Experimental group

Description:

COC + Vilaprisan (BAY 1002670)

Treatment:

Drug: Vilaprisan (BAY 1002670)

Drug: Microgynon Placebo

Drug: Microgynon

COC + Placebo

Placebo Comparator group

Description:

COC + Placebo

Treatment:

Drug: Microgynon Placebo

Drug: Vilaprisan Placebo

Drug: Microgynon