Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Vilaprisan (BAY1002670); Matching Placebo
Intervention description: Intake orally, once daily; Intake orally, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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)