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

Clinical Trial, Phase I Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262663
• Other study ID #: 15818
• Secondary ID: 2014-000329-19
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2014
• Last updated: March 14, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Clinical Trial, Phase I

Intervention

Drug:
• Vilaprisan (BAY1002670)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Number of subjects without bleeding/spotting		After three month treatment	No
Secondary	Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling		After three month treatment	No
Secondary	Number of subjects with TEAEs (treatment-emergent adverse events)		After three month treatment and during follow-up (up to 60 days)	Yes
Secondary	Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)		After three month treatment and during follow-up (up to 60 days)	Yes

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