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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2019-01-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Clinical Trial ,Phase I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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COC + Vilaprisan

COC + Vilaprisan (BAY 1002670)

Group Type EXPERIMENTAL

Vilaprisan (BAY 1002670)

Intervention Type DRUG

Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.

Microgynon

Intervention Type DRUG

Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)

Microgynon Placebo

Intervention Type DRUG

For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).

COC + Placebo

Group Type PLACEBO_COMPARATOR

Vilaprisan Placebo

Intervention Type DRUG

Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.

Microgynon

Intervention Type DRUG

Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)

Microgynon Placebo

Intervention Type DRUG

For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).

Interventions

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Vilaprisan (BAY 1002670)

Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.

Intervention Type DRUG

Vilaprisan Placebo

Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.

Intervention Type DRUG

Microgynon

Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)

Intervention Type DRUG

Microgynon Placebo

For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes