Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
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| ClinicalTrials.gov Identifier: NCT00737282 |
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Recruitment Status :
Terminated
(Repros stopped study for safety and FDA put study on hold.)
First Posted : August 18, 2008
Results First Posted : August 21, 2014
Last Update Posted : August 21, 2014
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Sponsor:
Repros Therapeutics Inc.
Information provided by (Responsible Party):
Repros Therapeutics Inc.
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Brief Summary:
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uterine Fibroids | Drug: Proellex 25 mg Drug: Proellex 50 mg | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 175 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | August 2009 |
| Actual Study Completion Date : | August 2009 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 25 mg Proellex
Proellex 25 mg once daily
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Drug: Proellex 25 mg
One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Other Name: Telapristone acetate |
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Active Comparator: Proellex 50 mg
Proellex 50 mg once daily
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Drug: Proellex 50 mg
Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Other Name: Telapristone acetate |
Primary Outcome Measures :
- To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle) [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years to 48 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737282
Locations
Show 25 study locations
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
| Study Director: | Andre vanAs, MD, PhD | Repros Therapeutics Inc. |
| Responsible Party: | Repros Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT00737282 |
| Other Study ID Numbers: |
ZPU-305 |
| First Posted: | August 18, 2008 Key Record Dates |
| Results First Posted: | August 21, 2014 |
| Last Update Posted: | August 21, 2014 |
| Last Verified: | August 2014 |
Keywords provided by Repros Therapeutics Inc.:
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Uterine Fibroids |
Additional relevant MeSH terms:
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Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |