Clinical trial NCT03573336: Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD])
timeFrame: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
Secondary outcomes:
measure: 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
timeFrame: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
measure: Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)
timeFrame: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
measure: Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP)
timeFrame: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days)
measure: The Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 6 months
measure: Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings
timeFrame: Up to 6 months
measure: Number of Participants With Clinical Significant Abnormal Ultrasound Examinations
timeFrame: Up to 6 months
measure: Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements
timeFrame: Up to 6 months
measure: Number of Participants With Clinical Significant Abnormal Laboratory Values
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Office of Dr. James A. Simon, MD
state: District of Columbia
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Metairie
country: United States
facility: Southern Clinical Research Associates LLC
state: Louisiana
city: Morehead City
country: United States
facility: Unified Women's Clinical Research - Morehead City
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Campus IV
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Villach
country: Austria
facility: KABEG Landeskrankenhaus Villach
city: Wien
country: Austria
facility: Universitätsklinikum AKH Wien
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital-Riverside Campus
state: Ontario
city: Montreal
country: Canada
facility: Clinique OVO
state: Quebec
city: Brno
country: Czechia
facility: Gynekologie MEDA s.r.o.
city: Plzen
country: Czechia
facility: GynCare MUDr. Michael Svec s.r.o.
city: Helsinki
country: Finland
facility: VL-Medi Oy
city: Pori
country: Finland
facility: Satakunnan keskussairaala
city: Verona
country: Italy
facility: A.O.U.I. Verona
state: Veneto
city: Sapporo
country: Japan
facility: Tokeidai Memorial Clinic
state: Hokkaido
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Lublin
country: Poland
facility: Centrum Medyczne Chodzki
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: