NCT02262663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

October 9, 2014

Last Update Submit

March 14, 2016

Conditions

Clinical Trial, Phase I

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • 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)

Study Arms (4)

Vilaprisan [0.5mg]

EXPERIMENTAL

0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Drug: Vilaprisan (BAY1002670)

Vilaprisan [1mg]

EXPERIMENTAL

1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Drug: Vilaprisan (BAY1002670)

Vilaprisan [2mg]

EXPERIMENTAL

2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Drug: Vilaprisan (BAY1002670)

Vilaprisan [4mg]

EXPERIMENTAL

4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days

Drug: Vilaprisan (BAY1002670)

Interventions

Vilaprisan (BAY1002670)DRUG
Vilaprisan [0.5mg]Vilaprisan [1mg]Vilaprisan [2mg]Vilaprisan [4mg]

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Interventions

vilaprisan

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 13, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

DE(2)