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

Phase 1

Completed

• Conditions: Clinical Trial, Phase I
• Interventions: Drug: Vilaprisan (BAY1002670)

• Registration Number: NCT02262663
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-13
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vilaprisan [1mg]	Vilaprisan (BAY1002670)	1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
Vilaprisan [2mg]	Vilaprisan (BAY1002670)	2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
Vilaprisan [0.5mg]	Vilaprisan (BAY1002670)	0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
Vilaprisan [4mg]	Vilaprisan (BAY1002670)	4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Primary Outcome Measures

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

Secondary Outcome Measures

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