Trial Condition(s):
Endometriosis
Assess safety and efficacy of vilaprisan in subjects with endometriosis (VILLENDO)
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Office of Dr. James A. Simon, MD Washington, United States, 20036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Unified Women's Clinical Research - Morehead City Morehead City, United States, 28557 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ottawa Hospital-Riverside Campus Ottawa, Canada, K1H 7W9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Clinique OVO Montreal, Canada, H4P 2S4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kepler Universitätsklinikum Campus IV Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations KABEG Landeskrankenhaus Villach Villach, Austria, 9500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Solutions Through Advanced Research, Inc. Jacksonville, United States, 32256 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Queen's University Kingston, Canada, K7L 2V7 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations VL-Medi Oy Helsinki, Finland, 00510 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Satakunnan keskussairaala Pori, Finland, 28500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations A.O.U.I. Verona Verona, Italy, 37126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Unified Women's Clinical Research Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Southern Clinical Research Associates LLC Metairie, United States, 70001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Helix Biomedics, LLC Boynton Beach, United States, 33435 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations GynCare MUDr. Michael Svec s.r.o. Plzen, Czech Republic, 326 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Gynekologie MEDA s.r.o. Brno, Czech Republic, 602 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Centrum Medyczne Chodzki Lublin, Poland, 20-093 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tokeidai Memorial Clinic Sapporo, Japan, 060-0031 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ishikawa Prefectural Central Hospital Kanazawa, Japan, 920-8530 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Toyama Prefectural Central Hospital Toyama, Japan, 930-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A randomized, double-blind, parallel-group, multicenter Phase 2b study to assess the efficacy and safety of two different doses of vilaprisan (BAY1002670) versus placebo in women with symptomatic endometriosis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- 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.Timeframe: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
Secondary Outcome
- Mean worst pelvic pain (measured on a numerical rating scale [NRS], recorded in the daily endometriosis symptom diary [ESD]) on days with/without vaginal bleedingPain 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’ on bleeding/non-bleeding days was calculated as the sum of the participant’s daily assessments of the ESD item 1 (“worst pain” during the last 24 hours) on bleedings/non-bleeding days during a study period divided by number of bleeding/non-bleeding days with pain assessment in that study period. This was summarized by study period. No inferential statistical analysis was performed.Timeframe: 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)Mean number of tablets of rescue pain medication 1 (Ibuprofen 200 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.Timeframe: 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)Mean number of tablets of rescue pain medication 2 (Tramadol 50 mg) taken daily for EAPP was calculated as the sum of the tablets taken for EAPP during a study period divided by the number of days in that study period. This was summarized by study period. No inferential statistical analysis was performed.Timeframe: 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)Timeframe: Up to 6 months
- Number of participants with clinical significant abnormal endometrial histology findingsTimeframe: Up to 6 months
- Number of participants with clinical significant abnormal ultrasound examinationsTimeframe: Up to 6 months
- Number of participants with clinical significant abnormal bone mineral density measurementsTimeframe: Up to 6 months
- Number of participants with clinical significant abnormal laboratory valuesTimeframe: Up to 6 months
Additional Information
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