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Completed

NCT Number: NCT02262663

Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan

This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.

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Key information

Conditions

Clinical Trial, Phase I

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, State of Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
  • Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
  • Pre-treatment cycle assessed as ovulatory and not longer than 44 days

Exclusion criteria

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
  • Known or suspected liver disorders
  • Amenorrhea for more than 3 months within the last 6 months before the first screening examination
  • Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
  • Positive urine pregnancy test
  • Regular use of medicines

Treatment and study plan

Vilaprisan (BAY1002670)

Drug

Primary outcomes

  1. Hoogland score during treatment, day 9 to day 28

    Time frame: Day 9 to 28

    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations

  2. Hoogland score during treatment, day 63 to day 84

    Time frame: Day 63 to 84

    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations

  3. Hoogland score during follow up cycle 1

    Time frame: 4 weeks following treatment period

    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations

  4. Hoogland score during follow up cycle 2

    Time frame: 4 weeks following follow up cycle 1

    based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations

  5. Number of subjects without bleeding/spotting

    Time frame: After three month treatment

Secondary outcomes

  1. Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling

    Time frame: After three month treatment

  2. Number of subjects with TEAEs (treatment-emergent adverse events)

    Time frame: After three month treatment and during follow-up (up to 60 days)

  3. Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)

    Time frame: After three month treatment and during follow-up (up to 60 days)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 13, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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