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

Clinical Trial ,Phase I Clinical Trial

Official title:

A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics and Pharmacokinetics of a Combined Oral Contraceptive Containing Levonorgestrel (LNG) and Ethinylestradiol (EE) When Given Together With Vilaprisan Over 3 Months in Healthy Women of Reproductive Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210246
• Other study ID #: 17670
• Secondary ID: 2016-004532-38
• Status: Completed
• Phase: Phase 1
• Start date: July 17, 2017
• Est. completion date: January 23, 2019

Study information

• Verified date: February 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 23, 2019
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Trial ,Phase I

Intervention

Drug:
• 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.
• Vilaprisan Placebo
Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
• Microgynon
Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)
• 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).

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin
Germany	Dinox GmbH Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)		treatment day 57 to day 84
Primary	Number of subjects with a Hoogland score = 4		treatment day 57 to day 84

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