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Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis (VILLENDO)

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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 : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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 amendment 6, 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 Design
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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

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. The Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 6 months ]
  5. Number of Participants With Clinical Significant Abnormal Endometrial Histology Findings [ Time Frame: Up to 6 months ]
  6. Number of Participants With Clinical Significant Abnormal Ultrasound Examinations [ Time Frame: Up to 6 months ]
  7. Number of Participants With Clinical Significant Abnormal Bone Mineral Density Measurements [ Time Frame: Up to 6 months ]
  8. Number of Participants With Clinical Significant Abnormal Laboratory Values [ Time Frame: Up to 6 months ]

Eligibility Criteria
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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)
Contacts and Locations
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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
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Statistical Analysis Plan  [PDF] January 15, 2020
Study Protocol  [PDF] February 17, 2020

More Information
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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: January 22, 2021
Last Verified: January 2021

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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:
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Endometriosis