Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis
NCT ID: NCT03573336
Last Updated: 2022-05-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2018-07-04
2020-11-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vilaprisan (BAY1002670) 2 mg
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg
Vilaprisan (BAY1002670)
Intake orally, once daily
Vilaprisan (BAY1002670) 4 mg
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 4 mg
Vilaprisan (BAY1002670)
Intake orally, once daily
Placebo group
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1
Matching Placebo
Intake orally, once daily
Interventions
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Vilaprisan (BAY1002670)
Intake orally, once daily
Matching Placebo
Intake orally, once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Office of Dr. James A. Simon, MD
Washington D.C., District of Columbia, United States
Helix Biomedics, LLC
Boynton Beach, Florida, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
Southern Clinical Research Associates LLC
Metairie, Louisiana, United States
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States
Medizinische Universität Graz
Graz, Styria, Austria
Kepler Universitätsklinikum Campus IV
Linz, Upper Austria, Austria
Universitätsklinikum AKH Wien
Vienna, , Austria
KABEG Landeskrankenhaus Villach
Villach, , Austria
Queen's University
Kingston, Ontario, Canada
Ottawa Hospital-Riverside Campus
Ottawa, Ontario, Canada
Clinique OVO
Montreal, Quebec, Canada
Gynekologie MEDA s.r.o.
Brno, , Czechia
GynCare MUDr. Michael Svec s.r.o.
Pilsen, , Czechia
VL-Medi Oy
Helsinki, , Finland
Satakunnan keskussairaala
Pori, , Finland
A.O.U.I. Verona
Verona, Veneto, Italy
Tokeidai Memorial Clinic
Sapporo, Hokkaido, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Centrum Medyczne Chodzki
Lublin, , Poland
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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
Other Identifiers
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2013-004768-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15792
Identifier Type: -
Identifier Source: org_study_id
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