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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00785356
Other study ID # ZPU-302
Secondary ID
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


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
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