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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00737282
Other study ID # ZPU-305
Secondary ID
Status Terminated
Phase Phase 3
First received August 14, 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

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.


Description:

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.


Recruitment information / eligibility

Status Terminated
Enrollment 175
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:

- Speak, read and understand English or Spanish;

- Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;

- One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;

- Menstrual cycle lasting from 24 to 36 days;

- History of excessive menstrual bleeding;

- Negative urine pregnancy test at screening.

Additional inclusion criteria may apply.

Exclusion Criteria:

- Six months or more (immediately prior to Screening Visit) without a menstrual period;

- Prior hysterectomy;

- Prior bilateral oophorectomy;

- Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;

- Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;

- Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);

- Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;

- Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Additional exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Proellex 25 mg
One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Proellex 50 mg
Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Locations

Country Name City State
United States ClinSite, LLC Ann Arbor Michigan
United States Atlanta Women's Research Inst Atlanta Georgia
United States Women Partners in Health Austin Texas
United States Impact Clinical Trials Beverly Hills California
United States Medical Network for Education and Research Decatur Georgia
United States Soapstone Center for Clinical Research Decatur Georgia
United States Clinical Trials of America Eugene Oregon
United States NECCR Falls River LLC Fall River Massachusetts
United States Female Pelvic Medicine Grand Rapids Michigan
United States Greenville Pharmaceutical Research Greenville South Carolina
United States University Medical Group, Dept of OB/GYN Greenville South Carolina
United States AWC Clinical Trials LLC Little Rock Arkansas
United States Lynn Institute of the Ozarks Little Rock Arkansas
United States York Clinical Consulting Marrero Louisiana
United States Memphis Women's Healthcare Memphis Tennessee
United States Women's Care Center, PLC Research Memphis Associates Memphis Tennessee
United States Medical Associates Inc. Menomonee Falls Wisconsin
United States Meharry Medical College Nashville Tennessee
United States Alegent Research Omaha Nebraska
United States Thomas Jefferson University - Jefferson Center for Women's Medical Specialties Philadelphia Pennsylvania
United States Willowbend Health & Wellness Associates Plano Texas
United States Genesis Center for Clinical Research San Diego California
United States Physician Care Clinical Research, LLC Sarasota Florida
United States Hawthorne Medical Research, Inc. Winston-Salem North Carolina
United States Lyndhurst Gynecologic Associates Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle) 12 months Yes
See also
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