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

NCT03210246 | Completed Phase 1

• 2 other identifiers: 176702016-004532-38
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

Clinical Trial ,Phase I

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

COC + Vilaprisan

EXPERIMENTAL

COC + Vilaprisan (BAY 1002670)

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

COC + Placebo

PLACEBO COMPARATOR

COC + Placebo

Drug: Vilaprisan Placebo; Drug: Microgynon; Drug: Microgynon Placebo

Interventions

Vilaprisan (BAY 1002670) DRUG

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

COC + Vilaprisan

Vilaprisan Placebo DRUG

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

COC + Placebo

Microgynon DRUG

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

COC + Placebo; COC + Vilaprisan

Microgynon Placebo 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; COC + Vilaprisan

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Dinox GmbH Berlin

Berlin, 10115, Germany

Location

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

MeSH Terms

Interventions

vilaprisan; ethinyl estradiol, levonorgestrel drug combination

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 6, 2017
• Study Start: July 17, 2017
• Primary Completion: June 21, 2018
• Study Completion: January 23, 2019
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

DE (2)