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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 : Active, not recruiting
First Posted : June 29, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The primary objective of this study is 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 is to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.

With the implementation of protocol amendment 8, no new subjects will be 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

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Study Type : Interventional
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
Estimated Study Completion Date : September 30, 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 :
  1. The change in the subject's 7-day mean 'worst pain' from baseline to month 3 [ Time Frame: Month 3 of the first 24 weeks treatment period ]
    Measured on a series of 0-10 Numerical Rating Scale named ESD (Endometriosis Symptom Diary). Lower scores correspond to lower level of pain, higher scores correspond to higher level of pain.


Secondary Outcome Measures :
  1. The proportion of subjects with an improvement of the subject's mean 'worst pain' on bleeding days from baseline with no increase in rescue pain medication use [ Time Frame: Month 3 ]
    Measured on a series of 0-10 Numerical Rating Scale named ESD (Endometriosis Symptom Diary). Lower scores correspond to lower level of pain, higher scores correspond to higher level of pain.

  2. The proportion of subjects with an improvement of the subject's mean 'worst pain' on non-bleeding days from baseline with no increase in rescue pain medication use [ Time Frame: Month 3 ]
    Measured on a series of 0-10 Numerical Rating Scale named ESD (Endometriosis Symptom Diary). Lower scores correspond to lower level of pain, higher scores correspond to higher level of pain.

  3. The number of participants with adverse events [ Time Frame: 33 months ]
  4. The number of clinical significant abnormal of endometrial histology [ Time Frame: 33 months ]
  5. The number of clinical significant abnormal of ultrasound examinations [ Time Frame: 33 months ]
  6. The number of clinical significant abnormal of bone mineral density [ Time Frame: 33 months ]
  7. The number of clinical significant abnormal of laboratory parameters [ Time Frame: 33 months ]


Information from the National Library of Medicine

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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

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 Show 23 study locations
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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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
Last Update Posted: May 27, 2020
Last Verified: May 2020

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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
Genital Diseases, Female