Clinical trial NCT00785356: Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Official title: A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Anemia
Keywords: Uterine fibroids
Anemia
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.

Detailed description: Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Eligibility criteria: Inclusion Criteria:

* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
* Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
* Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
* Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria:

* Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

  * Six months or more (immediately prior to Screening Visit) without a menstrual period, or
  * Prior hysterectomy, or
  * Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
* Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
* Documented endometriosis or active pelvic inflammatory disease (PID);
* Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
* Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
* Use of prohibited concomitant medications:

  1. Depo-Provera use must cease ten months prior to first dose of study drug, or
  2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
  3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study

Primary outcomes:
measure: The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toluca
country: Mexico
facility: Hospital Perinatal del Estado de Mexico del ISEM
state: Estado de Mexico C.P.
city: Mexico City
country: Mexico
facility: Comité para la Prevención de la Osteoporosis COMOP
state: Federal District
city: Mexico City
country: Mexico
facility: Centro Hospitalario Nuevo Sanatorio Durango
state: Federal District
city: Mexico City
country: Mexico
facility: Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"
state: Federal District
city: San Miguel de Allende
country: Mexico
facility: Hospital de la Fe
state: Gto
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. José Eleuterio González" Facultad de Medicina de la Universidad Autónoma de Nuevo León (UANL)
state: Nuevo León
city: Monterrey
country: Mexico
facility: MIRC (Monterrey International Research Center)
state: Nuevo León
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, MD, PhD
role: STUDY_DIRECTOR
References: