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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210246
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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Study Type : Interventional  (Clinical Trial)
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 : July 17, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : January 23, 2019

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).




Primary Outcome Measures :
  1. Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5) [ Time Frame: treatment day 57 to day 84 ]
  2. Number of subjects with a Hoogland score = 4 [ Time Frame: treatment day 57 to day 84 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210246


Locations
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Germany
Dinox GmbH Berlin
Berlin, Germany, 10115
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03210246    
Other Study ID Numbers: 17670
2016-004532-38 ( EudraCT Number )
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital