Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

NCT03573336 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 157922013-004768-72
• Study Type: interventional
• Target: 8
• Locations: 8 countries
• Sites: 23

Brief Summary

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD])

  Pain intensity was assessed on 11-point (0-10) NRS by ESD item 1. In ESD item 1, participants were asked to rate the worst pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. Mean 'worst pelvic pain' was calculated as the sum of the participant's daily assessments of the ESD item 1 ("worst pain" during the last 24 hours) during a study period divided by number of days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.

  Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

Secondary Outcomes (8)

• Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) on Days With/Without Vaginal Bleeding

  Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

• Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)

  Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

• Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)

  Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)

• The Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to 6 months

• Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings

  Up to 6 months

Study Arms (3)

Vilaprisan (BAY1002670) 2 mg

EXPERIMENTAL

Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg

Drug: Vilaprisan (BAY1002670)

Vilaprisan (BAY1002670) 4 mg

EXPERIMENTAL

Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 4 mg

Drug: Vilaprisan (BAY1002670)

Placebo group

PLACEBO COMPARATOR

Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1

Drug: Matching Placebo

Interventions

Vilaprisan (BAY1002670) DRUG

Intake orally, once daily

Vilaprisan (BAY1002670) 2 mg; Vilaprisan (BAY1002670) 4 mg

Matching Placebo DRUG

Intake orally, once daily

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before Visit 1)
• Hypersensitivity to any ingredient of the study treatments
• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (23)

Office of Dr. James A. Simon, MD

Washington D.C., District of Columbia, 20036, United States

Location

Helix Biomedics, LLC

Boynton Beach, Florida, 33435, United States

Location

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, 32256, United States

Location

Southern Clinical Research Associates LLC

Metairie, Louisiana, 70001, United States

Location

Unified Women's Clinical Research - Morehead City

Morehead City, North Carolina, 28557, United States

Location

Unified Women's Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Kepler Universitätsklinikum Campus IV

Linz, Upper Austria, 4020, Austria

Location

Universitätsklinikum AKH Wien

Vienna, 1090, Austria

Location

KABEG Landeskrankenhaus Villach

Villach, 9500, Austria

Location

Queen's University

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital-Riverside Campus

Ottawa, Ontario, K1H 7W9, Canada

Location

Clinique OVO

Montreal, Quebec, H4P 2S4, Canada

Location

Gynekologie MEDA s.r.o.

Brno, 602 00, Czechia

Location

GynCare MUDr. Michael Svec s.r.o.

Pilsen, 326 00, Czechia

Location

VL-Medi Oy

Helsinki, 00510, Finland

Location

Satakunnan keskussairaala

Pori, 28500, Finland

Location

A.O.U.I. Verona

Verona, Veneto, 37126, Italy

Location

Tokeidai Memorial Clinic

Sapporo, Hokkaido, 060-0031, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

Location

Toyama Prefectural Central Hospital

Toyama, 930-8550, Japan

Location

Centrum Medyczne Chodzki

Lublin, 20-093, Poland

Location

Related Publications (1)

• Taylor HS, Dong L, Haikonen J, Oppelt P, Tamussino K, Wenzl R, Faustmann T, Groettrup-Wolfers E, Ren X, Seitz C. Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial. F S Rep. 2024 Mar 11;5(2):189-196. doi: 10.1016/j.xfre.2024.03.002. eCollection 2024 Jun.

  PMID: 38983729 DERIVED

Related Links

• Click here to find results for studies related to Bayer products
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Endometriosis

Interventions

vilaprisan

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

No inferential statistical analysis was performed due to a small population.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+)1-888-84 22937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 29, 2018
• Study Start: July 4, 2018
• Primary Completion: March 18, 2019
• Study Completion: November 26, 2020
• Last Updated: May 4, 2022
• Results First Posted: January 22, 2021

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4); CA (3); CZ (2); IT (1); FI (2); AU (4); US (6); PL (1)