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

NCT00785356 | Terminated Phase 3 Results DMC

• 1 other identifier: ZPU-302
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 7

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.

Conditions

Uterine Fibroids; Anemia

Keywords

Uterine fibroids; Anemia

Outcome Measures

Primary Outcomes (1)

• The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.

  3 months

Study Arms (3)

25 mg Proellex

EXPERIMENTAL

Proellex 25 mg

Drug: Proellex 25 mg

Proellex 50 mg

EXPERIMENTAL

Proellex 50 mg

Drug: Proellex 50 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Proellex 25 mg DRUG

Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months

Also known as: Telapristone acetate

25 mg Proellex

Proellex 50 mg DRUG

Proellex 50 mg, 2 - 25 mg capsules daily for 3 months

Also known as: Telapristone acetate

Proellex 50 mg

Placebo DRUG

Placebo, 2 capsules daily for 3 months

Also known as: Sugar pill, Dummy

Placebo

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (7)

Hospital Perinatal del Estado de Mexico del ISEM

Toluca, Estado de Mexico C.P., 50120, Mexico

Location

Comité para la Prevención de la Osteoporosis COMOP

Mexico City, Federal District, 06100, Mexico

Location

Centro Hospitalario Nuevo Sanatorio Durango

Mexico City, Federal District, 06700, Mexico

Location

Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"

Mexico City, Federal District, 11000, Mexico

Location

Hospital de la Fe

San Miguel de Allende, Guanajuato, 37775, Mexico

Location

Hospital Universitario "Dr. José Eleuterio González" Facultad de Medicina de la Universidad Autónoma de Nuevo León (UANL)

Monterrey, Nuevo León, 64460, Mexico

Location

MIRC (Monterrey International Research Center)

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Leiomyoma; Anemia

Interventions

telapristone acetate; Sugars

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

Results Point of Contact

• Title: Jennifer Wike
• Organization: Repros Therapeutics Inc.

jwike@reprosrx.com

2817193402

Study Officials

• Andre van As, MD, PhD

  Repros Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 21, 2014
• Results First Posted: August 21, 2014

Record last verified: 2014-08

Locations

ME (7)