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

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

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.

Study Overview

• Status: Completed
• Conditions: Clinical Trial, Phase I
• Intervention / Treatment: Drug: Vilaprisan (BAY1002670)

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
  • Berlin, Germany, 10115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vilaprisan [0.5mg]; 0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days	Drug: Vilaprisan (BAY1002670)
Experimental: Vilaprisan [1mg]; 1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days	Drug: Vilaprisan (BAY1002670)
Experimental: Vilaprisan [2mg]; 2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days	Drug: Vilaprisan (BAY1002670)
Experimental: Vilaprisan [4mg]; 4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days	Drug: Vilaprisan (BAY1002670)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hoogland score during treatment, day 9 to day 28	based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations	Day 9 to 28
Hoogland score during treatment, day 63 to day 84	based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations	Day 63 to 84
Hoogland score during follow up cycle 1	based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations	4 weeks following treatment period
Hoogland score during follow up cycle 2	based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations	4 weeks following follow up cycle 1
Number of subjects without bleeding/spotting		After three month treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling	After three month treatment
Number of subjects with TEAEs (treatment-emergent adverse events)	After three month treatment and during follow-up (up to 60 days)
Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)	After three month treatment and during follow-up (up to 60 days)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 15818; 2014-000329-19 (EudraCT Number)