NCT01816815

Brief Summary

Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship

Trial Health

90
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Geographic Reach
3 countries

6 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

November 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

March 20, 2013

Last Update Submit

April 18, 2014

Conditions

Leiomyoma

Keywords

PK/PDBAY1002670

Outcome Measures

Primary Outcomes (1)

  • Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)

    After three months

Secondary Outcomes (1)

  • Return of menstrual bleeding after treatment

    Up to two months after last treatment

Study Arms (6)

BAY1002670 [0.1mg]

EXPERIMENTAL

0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Drug: BAY1002670

BAY1002670 [0.5mg]

EXPERIMENTAL

0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Drug: BAY1002670

BAY1002670 [1.0mg]

EXPERIMENTAL

1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Drug: BAY1002670

BAY1002670 [2.0mg]

EXPERIMENTAL

2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Drug: BAY1002670

BAY1002670 [5.0mg]

EXPERIMENTAL

5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Drug: BAY1002670

Placebo

PLACEBO COMPARATOR

Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Drug: Placebo

Interventions

BAY1002670DRUG
BAY1002670 [0.1mg]BAY1002670 [0.5mg]BAY1002670 [1.0mg]BAY1002670 [2.0mg]BAY1002670 [5.0mg]
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female subjects
  • Sterilized by tubal ligation
  • Age 18-45 years
  • Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
  • At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
  • Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy

You may not qualify if:

  • Regular use of medicines (incl. anabolics)
  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Amenorrhea for more than 3 months within the last 6 months before the first screening examination
  • Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
  • Clinically relevant findings (e.g. blood pressure, electrocardiogram \[ECG\], physical and gynecological examination, laboratory examination)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Antwerp, 2060, Belgium

Location

Unknown Facility

Neu-Ulm, Bavaria, 89231, Germany

Location

Unknown Facility

Neuss, North Rhine-Westphalia, 41450, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10117, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Belfast, Belfast, BT2 7BA, United Kingdom

Location

Related Publications (1)

  • Schutt B, Kaiser A, Schultze-Mosgau MH, Seitz C, Bell D, Koch M, Rohde B. Pharmacodynamics and safety of the novel selective progesterone receptor modulator vilaprisan: a double-blind, randomized, placebo-controlled phase 1 trial in healthy women. Hum Reprod. 2016 Aug;31(8):1703-12. doi: 10.1093/humrep/dew140. Epub 2016 Jun 10.

    PMID: 27288475DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

vilaprisan

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

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

March 20, 2013

First Posted

March 22, 2013

Study Start

November 1, 2011

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

DE(4)BE(1)GB(1)