Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis (VILLENDO)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03573336 |
|
Recruitment Status :
Terminated
(Due to a change in the development program, the study was closed prematurely.)
First Posted : June 29, 2018
Results First Posted : January 22, 2021
Last Update Posted : May 4, 2022
|
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Endometriosis | Drug: Vilaprisan (BAY1002670) Drug: Matching Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 8 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 4, 2018 |
| Actual Primary Completion Date : | March 18, 2019 |
| Actual Study Completion Date : | November 26, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Endometriosis
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Vilaprisan (BAY1002670) 2 mg
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg
|
Drug: Vilaprisan (BAY1002670)
Intake orally, once daily |
|
Experimental: Vilaprisan (BAY1002670) 4 mg
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 4 mg
|
Drug: Vilaprisan (BAY1002670)
Intake orally, once daily |
|
Placebo Comparator: Placebo group
Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1
|
Drug: Matching Placebo
Intake orally, once daily |
Primary Outcome Measures :
- Mean Worst Pelvic Pain (Measured on a Numerical Rating Scale [NRS], Recorded in the Daily Endometriosis Symptom Diary [ESD]) [ Time Frame: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) ]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.
Secondary Outcome Measures :
- 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 [ Time Frame: Screening period (up to a maximum of 75 days) + treatment period (up to a maximum of 168 days) ]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' 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.
- Mean Number of Tablets of Rescue Pain Medication 1 (Ibuprofen 200 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) [ Time Frame: 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 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.
- Mean Number of Tablets of Rescue Pain Medication 2 (Tramadol 50 mg) Taken Daily for Endometriosis-associated Pelvic Pain (EAPP) [ Time Frame: 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 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.
- The Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 6 months ]An adverse event (AE) is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. TEAE is defined as AE that is observed or reported after the first administration of study drug or if it starts before the first administration of study drug and the intensity/grade worsens on treatment) in this study.
- Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings [ Time Frame: Up to 6 months ]Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps
- Number of Participants With Clinical Significant Abnormal Ultrasound Examinations [ Time Frame: Up to 6 months ]Ultrasound examinations (evaluated for efficacy and safety) will be performed by a qualified expert in performing gynecologic ultrasound exams. If possible, the same examiner should conduct all examinations of a subject throughout the study and the same ultrasound machine (per site) should be used throughout the study. Preferably the safety evaluation should be performed by transvaginal ultrasound (TVU). However, if deemed appropriate, transabdominal or transrectal ultrasound examinations can be performed instead. The chosen method should be used consistently throughout the study.
- Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements [ Time Frame: Up to 6 months ]A Dual-energy X-ray absorptiometry (DEXA) scan of the lumbar spine (lumbar anterior-posterior, L1-L4) and the hip/femoral neck were performed.
- Number of Participants With Clinical Significant Abnormal Laboratory Values [ Time Frame: Up to 6 months ]Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573336
Locations
Show 23 study locations
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Study Documents (Full-Text)
Documents provided by Bayer:
Documents provided by Bayer:
Study Protocol [PDF] February 17, 2020
Statistical Analysis Plan [PDF] January 15, 2020
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT03573336 |
| Other Study ID Numbers: |
15792 2013-004768-72 ( EudraCT Number ) |
| First Posted: | June 29, 2018 Key Record Dates |
| Results First Posted: | January 22, 2021 |
| Last Update Posted: | May 4, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
|
Endometriosis |