EndometriosisPhase 2VILLENDONCT03573336
Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis
A Phase 2 study testing Vilaprisan (BAY1002670) in people with Endometriosis, run by Bayer at 23 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Vilaprisan (BAY1002670)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 4 Jul 2018to 26 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States6 sites
Helix Biomedics, LLC
Boynton Beach, Florida, 33435
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256
Southern Clinical Research Associates LLC
Metairie, Louisiana, 70001
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, 28557
Office of Dr. James A. Simon, MD
Washington D.C., District of Columbia, 20036
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103
Austria4 sites
Medizinische Universität Graz
Graz, Styria, 8036
Kepler Universitätsklinikum Campus IV
Linz, Upper Austria, 4020
Universitätsklinikum AKH Wien
Vienna, 1090
KABEG Landeskrankenhaus Villach
Villach, 9500
Japan4 sites
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520
Tokeidai Memorial Clinic
Sapporo, Hokkaido, 060-0031
Toyama Prefectural Central Hospital
Toyama, 930-8550
Canada3 sites
Queen's University
Kingston, Ontario, K7L 2V7
Clinique OVO
Montreal, Quebec, H4P 2S4
Ottawa Hospital-Riverside Campus
Ottawa, Ontario, K1H 7W9
Czechia2 sites
Gynekologie MEDA s.r.o.
Brno, 602 00
GynCare MUDr. Michael Svec s.r.o.
Pilsen, 326 00
Finland2 sites
VL-Medi Oy
Helsinki, 00510
Satakunnan keskussairaala
Pori, 28500
About this study
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
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
- Being tested
- Vilaprisan (BAY1002670), Matching Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilaprisan (BAY1002670)Drug
Intake orally, once daily
Matching PlaceboDrug
Intake orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Experimental | Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg Receives: 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 Receives: Drug: Vilaprisan (BAY1002670) |
| Placebo group | Placebo comparator | Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Up to 6 months
Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings
Number of participants with endometrial histology findings, e.g. hyperplasia, malignant neoplasm or endometrial polyps
Measured: Up to 6 months
Number of Participants With Clinical Significant Abnormal Ultrasound Examinations
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.
Measured: Up to 6 months
Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements
A Dual-energy X-ray absorptiometry (DEXA) scan of the lumbar spine (lumbar anterior-posterior, L1-L4) and the hip/femoral neck were performed.
Measured: Up to 6 months
Number of Participants With Clinical Significant Abnormal Laboratory Values
Clinical laboratory values including the values of hematology, general chemistry, urinalysis, coagulation, hormones, immunology and vitamins.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start4 Jul 2018
- Primary completion18 Mar 2019
- Study completion26 Nov 2020
Why it stopped: Due to a change in the development program, the study was closed prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573336
- Sponsor's protocol ID
- 15792
- Other IDs
- 2013-004768-72
- Acronym
- VILLENDO
- Status last verified
- Apr 2022
- First submitted
- 19 Jun 2018
- Last updated
- 4 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38983729
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03573336
- Acronym / sponsor ID
- VILLENDO / 15792
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a change in the development program, the study was closed prematurely.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vilaprisan (BAY1002670) 2 mg | Experimental | Drug: Vilaprisan (BAY1002670)Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 2 mg |
| Vilaprisan (BAY1002670) 4 mg | Experimental | Drug: Vilaprisan (BAY1002670)Premenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 Vilaprisan: 4 mg |
| Placebo group | Placebo comparator | Drug: Matching PlaceboPremenopausal women 18 years and older with endometriosis with randomized ratio = 1:1:1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vilaprisan (BAY1002670)Intake orally, once daily | Drug | Vilaprisan (BAY1002670) 2 mg, Vilaprisan (BAY1002670) 4 mg |
| Matching PlaceboIntake orally, once daily | Drug | Placebo group |
Primary outcome
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.
8 secondary outcomes
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)
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 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)
The Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 6 months
Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings
Time frame: Up to 6 months
Number of Participants With Clinical Significant Abnormal Ultrasound Examinations
Time frame: Up to 6 months
Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements
Time frame: Up to 6 months
Number of Participants With Clinical Significant Abnormal Laboratory Values
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38983729Taylor 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.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vilaprisan (BAY1002670) in people with Endometriosis, run by Bayer at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Austria, Japan, Canada, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.