Trial Condition(s):

Endometriosis

Assess safety and efficacy of vilaprisan in subjects with endometriosis (VILLENDO)

Bayer Identifier:

15792

ClinicalTrials.gov Identifier:

NCT03573336

EudraCT Number:

2013-004768-72

EU CT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

The primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis.

The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.

With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.

Inclusion Criteria
- Signed and dated informed consent
- Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1
- Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on imaging
- Moderate to severe endometriosis-associated pelvic pain (EAPP)
- Adherence to screening period diary entries
- Willingness to use only standardized pain medication if needed
- Good general health (except for findings related to endometriosis)
- Normal or clinically insignificant cervical cytology not requiring further follow-up
- An endometrial biopsy performed at the screening phase without significant histological disorder
- Use of an acceptable non-hormonal method of contraception
- Willingness / ability to comply with electronic diary entry for the duration of study participation
Exclusion Criteria
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1)
- Hypersensitivity to any ingredient of the study treatments
- Laboratory values outside the inclusion range before randomization, and considered clinically relevant
- Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including elevated liver enzymes
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Undiagnosed abnormal genital bleeding
- Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the investigator
- Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
- Endometriosis-specific treatments for symptom relief except rescue pain medication according to protocol
- Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator
- Inability to cooperate with the study procedures for any reason
- Previous assignment to treatment (e.g. randomization) during this study (allowing previously randomized subjects to be re-included into the study may lead to bias)
- Hypersensitivity to any ingredient of standardized pain medication
- Wish for pregnancy during the study
- Regular use of pain medication due to other underlying diseases
- Non-responsiveness of EAPP to GnRH-a (Gonadotropin-releasing hormone agonists)

Trial Summary

Enrollment Goal
8
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Office of Dr. James A. Simon, MD

Washington, United States, 20036

Status
Completed
Locations

Unified Women's Clinical Research - Morehead City

Morehead City, United States, 28557

Status
Completed
Locations

Ottawa Hospital-Riverside Campus

Ottawa, Canada, K1H 7W9

Status
Completed
Locations

Clinique OVO

Montreal, Canada, H4P 2S4

Status
Completed
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
Locations

Kepler Universitätsklinikum Campus IV

Linz, Austria, 4020

Status
Completed
Locations

KABEG Landeskrankenhaus Villach

Villach, Austria, 9500

Status
Completed
Locations

Solutions Through Advanced Research, Inc.

Jacksonville, United States, 32256

Status
Completed
Locations

Queen's University

Kingston, Canada, K7L 2V7

Status
Completed
Locations

VL-Medi Oy

Helsinki, Finland, 00510

Status
Completed
Locations

Satakunnan keskussairaala

Pori, Finland, 28500

Status
Completed
Locations

A.O.U.I. Verona

Verona, Italy, 37126

Status
Completed
Locations

Unified Women's Clinical Research

Winston-Salem, United States, 27103

Status
Completed
Locations

Southern Clinical Research Associates LLC

Metairie, United States, 70001

Status
Completed
Locations

Helix Biomedics, LLC

Boynton Beach, United States, 33435

Status
Completed
Locations

GynCare MUDr. Michael Svec s.r.o.

Plzen, Czech Republic, 326 00

Status
Completed
Locations

Gynekologie MEDA s.r.o.

Brno, Czech Republic, 602 00

Status
Completed
Locations

Centrum Medyczne Chodzki

Lublin, Poland, 20-093

Status
Completed
Locations

Tokeidai Memorial Clinic

Sapporo, Japan, 060-0031

Status
Completed
Locations

Ishikawa Prefectural Central Hospital

Kanazawa, Japan, 920-8530

Status
Completed
Locations

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan, 861-8520

Status
Completed
Locations

Toyama Prefectural Central Hospital

Toyama, Japan, 930-8550

Status
Completed

Trial Design