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Repros stopped study due to safety and FDA placed study on hold
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Safety and efficacy study of 25 and 50 mg doses of Proellex
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg Proellex® | Active Comparator | 2, 25 mg capsules |
|
| 25 mg Proellex® | Active Comparator | 1, 25 mg capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proellex | Drug | 2, 25 mg capsules once per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) | During two 4 month treatment periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre vanAS, PhD, Md | Repros Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visions Clinical Research | Boynton Beach | Florida | 33472 | United States | ||
| Insignia Clinical Research (Tampa Bay Women's Center) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proellex® | 25 or 50 mg capsules once per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study prematurely terminated
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| ID | Title | Description |
|---|---|---|
| BG000 | 50 mg Proellex® | Proellex: 2, 25 mg capsules once per day |
| BG001 | 25 mg Proellex® | Proellex: 1, 25 mg capsule once per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) | Posted | During two 4 month treatment periods |
|
|
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No adverse events data is available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 50 mg Proellex® | Proellex: 2, 25 mg capsules once per day |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Wike | Repros Therapeutics Inc. | 2817193402 | jwike@reprosrx.com |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C461063 | telapristone acetate |
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| Proellex | Drug | 1, 25 mg capsule once per day |
|
|
| Tampa |
| Florida |
| 33067 |
| United States |
| Advances in Health Inc | Houston | Texas | 77030 | United States |
| The Women's Hospital of Texas, Clinical Research Center | Houston | Texas | 77054 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 25 mg Proellex® | Proellex: 1, 25 mg capsule once per day | 0 | 0 | 0 | 0 |
Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights