Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids

Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00785356
• Other study ID #: ZPU-302
• Status: Terminated
• Phase: Phase 3
• First received: November 3, 2008
• Last updated: August 5, 2014
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Proellex 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
• Proellex 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
• Placebo
Placebo, 2 capsules daily for 3 months

Locations

Country	Name	City	State
Mexico	Centro Hospitalario Nuevo Sanatorio Durango	Mexico City	Federal District
Mexico	Comité para la Prevención de la Osteoporosis COMOP	Mexico City	Federal District
Mexico	Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"	Mexico City	Federal District
Mexico	Hospital Universitario "Dr. José Eleuterio González" Facultad de Medicina de la Universidad Autónoma de Nuevo León (UANL)	Monterrey	Nuevo León
Mexico	MIRC (Monterrey International Research Center)	Monterrey	Nuevo León
Mexico	Hospital de la Fe	San Miguel de Allende	Gto
Mexico	Hospital Perinatal del Estado de Mexico del ISEM	Toluca	Estado de Mexico C.P.

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.		3 months	Yes