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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03210246

Collaborator

(none)

Enrollment

Locations

Arms

18.2

Actual Duration (Months)

35.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Trial ,Phase I	Drug: Vilaprisan (BAY 1002670) Drug: Vilaprisan Placebo Drug: Microgynon Drug: Microgynon Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

Jul 17, 2017

Actual Primary Completion Date :

Jun 21, 2018

Actual Study Completion Date :

Jan 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COC + Vilaprisan COC + Vilaprisan (BAY 1002670)	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. Drug: Microgynon Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21) 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).
Placebo Comparator: COC + Placebo COC + Placebo	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. Drug: Microgynon Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21) 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).

Arm

Intervention/Treatment

Experimental: COC + Vilaprisan

COC + Vilaprisan (BAY 1002670)

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.

Drug: Microgynon

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

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).

Placebo Comparator: COC + Placebo

COC + Placebo

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.

Drug: Microgynon

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

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).

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dinox GmbH Berlin	Berlin		Germany	10115
2	CRS Clinical Research Services Berlin GmbH	Berlin		Germany	13353

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT03210246

Other Study ID Numbers:

17670
2016-004532-38

First Posted:

Jul 6, 2017

Last Update Posted:

Feb 28, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ethinyl estradiol, levonorgestrel drug combination

Ethinyl Estradiol-Norgestrel Combination

Study Results

No Results Posted as of Feb 28, 2019