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A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response


Phase 2
18 Years
45 Years
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response


Inclusion Criteria:



- Female subjects between the ages of 18 and 45 years with body mass index (BMI)
between 18 and 35 mg/kg2 inclusive

- Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or
uterine arterial embolization) must not be planned or anticipated during the study

- Subject must have the following uterine fibroid-associated symptom: history of
excessive menstrual bleeding

- Regular or steady menstrual cycle lasting from 24 to 36 days

- Willing to comply with all study procedures including the endometrial biopsies and PK
blood draws for all visits including follow-up visits

- Subject must agree to use a medically acceptable and effective non-hormonal, double
barrier birth control method throughout the study and for 30 days following the end
of the study or discontinuation of study drug

Exclusion Criteria:

- Documented endometriosis or active pelvic inflammatory disease

- History of alcohol and/or drug abuse

- Any history or diagnosis of gynecological cancer or cervical dysplasia

- Use of an IUD

- Use of prohibited concomitant medications:

- Use of Depo-Provera must cease 10 months prior to first dose of study drug

- Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of
study drug and Lupton® Depot 8 months prior to the first visit

- Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

The primary outcome measure is the PK characteristics of 25 mg and 50 mg Proellex.

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Andre vanAs, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Repros Therapeutics Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ZPU-202

NCT ID:

NCT00683917

Start Date:

May 2008

Completion Date:

August 2009

Related Keywords:

  • Uterine Fibroids
  • Uterine fibroids
  • Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Physician Care Clinical ResearchSarasota, Florida  34239
West Houston Clinical Research ServicesHouston, Texas  77055
Advances in Health, Inc.Houston, Texas  77030