Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex
Intervention description: vaginal suppository, daily, for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 47 Years
Healthy volunteers: No

Summary:

      To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of
      Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be
      administered vaginally.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed
             by ultrasound.

          -  Normal transvaginal ultrasound (other than for presence of fibroids)

          -  History of menstrual events occurring in regular cycles

          -  Agreement not to attempt to become pregnant

          -  Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid
             alcohol consumption within 48 hours before each visit

          -  Ability to complete a daily subject diary

          -  Willing to discontinue hormonal contraceptives and consent to use of double barrier
             contraceptive techniques over the course of the study.

          -  Has a negative pregnancy test at the Screening and Baseline visits An exception for
             the pregnancy test requirement will be granted for subjects reporting surgical
             sterilization in medical history

          -  A Body Mass Index (BMI) between 18 and 39 inclusive

          -  Is available for all treatment and follow-up visits.

        Exclusion Criteria:

          -  Subject is a 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

          -  Subject is pregnant or lactating or is attempting or expecting to become pregnant
             during the 6 month study period

          -  Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding
             1.5xULN AND total bilirubin exceeding 1.5xULN at screening and confirmed on repeat).

          -  Received an investigational drug in the 30 days prior to the screening for this study

          -  Women with a history of PCOS

          -  Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
             DHEA or hormonal products for at least 2 weeks prior to screening and during the
             study.

          -  Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the
             preceding 6 months.

          -  Has an IUD in place

          -  Women currently using narcotics

          -  Women currently taking spironolactone

          -  Infectious disease screen is positive for HIV or Hepatitis A, B or C

          -  Clinically significant abnormal findings on screening examination 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