Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics

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 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.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03210246
Study type	Interventional
Source	Bayer
Contact
Status	Completed
Phase	Phase 1
Start date	July 17, 2017
Completion date	January 23, 2019

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms