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

Phase 1

Completed

• Conditions: Clinical Trial ,Phase I
• Interventions: Drug: Vilaprisan (BAY 1002670); Drug: Vilaprisan Placebo; Drug: Microgynon; Drug: Microgynon Placebo

• Registration Number: NCT03210246
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-06
• Study Start: 2017-07-17
• Primary Completion: 2018-06-21
• Study Completion: 2019-01-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COC + Vilaprisan	Vilaprisan (BAY 1002670)	COC + Vilaprisan (BAY 1002670)
COC + Vilaprisan	Microgynon	COC + Vilaprisan (BAY 1002670)
COC + Vilaprisan	Microgynon Placebo	COC + Vilaprisan (BAY 1002670)
COC + Placebo	Vilaprisan Placebo	COC + Placebo
COC + Placebo	Microgynon	COC + Placebo
COC + Placebo	Microgynon Placebo	COC + Placebo

Primary Outcome Measures

Name	Time	Method
Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)	treatment day 57 to day 84
Number of subjects with a Hoogland score = 4	treatment day 57 to day 84

Trial Locations

Locations (2)

Dinox GmbH Berlin; 🇩🇪 Berlin, Germany

CRS Clinical Research Services Berlin GmbH; 🇩🇪 Berlin, Germany