Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Placebo; Telapristone Acetate
Intervention description: Matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.; Telapristone acetate, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Maximum age: 47 Years
Healthy volunteers: No
Keywords: uterine fibroids; leiomyoma; fibroid tumor; fibroma

Summary:

      The primary objective of this study is to determine the safety and efficacy of two vaginal
      doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each
      separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine
      fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult females between 18 and 47 years.

          -  Have a history of at least 3 regular menstrual cycles in which menorrhagia is due to
             uterine fibroids.

          -  Must have uterine fibroids.

          -  Agreement not to attempt to become pregnant during the trial.

          -  Agreement to use only sanitary pads provided throughout the course of the study,
             tampon use is prohibited .

          -  Ability to complete a daily Participant diary and study procedures in compliance with
             the protocol.

          -  Have a negative pregnancy test at the Screening and Baseline visits, and subsequent
             study visits.

          -  A Body Mass Index (BMI) between 18 and 45 inclusive.

          -  Menstrual blood loss > 80 milliliters (mL) by alkaline hematin assay.

        Exclusion Criteria:

          -  Post-menopausal woman, defined as either; six (6) months or more (immediately prior to
             screening visit) without a menstrual period, or prior hysterectomy and/or
             oophorectomy.

          -  Pregnant or lactating or is attempting or expecting to become pregnant during the
             entire study period.

          -  Received an investigational drug in the 30 days prior to the screening for this study.

          -  History of Polycystic Ovarian Syndrome (PCOS).

          -  Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
             Dihydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to
             screening and during the study.

          -  Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the
             preceding 10 months.

          -  Use of Gonadotropin Releasing Hormone (GnRHas) (e.g. Lupron Depot) within 3 months of
             the first dose of study drug (Lupron Depot must have a wash-out period of 3 months).

          -  Has an Intra Uterine device (IUD) in place.

          -  Known or suspected carcinoma of the breast or reproductive organs.

          -  Recent history (within past 6 months) of alcoholism or drug abuse.

          -  Clinically significant abnormal findings on screening examination and laboratory
             assessments or any condition which in the opinion of the investigator would interfere
             with the participant's ability to comply with the study instructions or endanger the
             participant if she took part in the study.