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Repros stopped the study for safety and FDA put the study on hold for safety.
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ZPE-201 Extension of treatment
This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proellex® | Experimental | 25 mg Proellex® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proellex® | Drug | one (1) 25 mg capsule daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily | Number of participants who experienced 1 or more adverse event. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Chan | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Therapeutics, LLC | Tucson | Arizona | 85712 | United States | ||
| Medical Center for Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proellex | Proellex: one (1) 25 mg capsule daily Study was terminated prematurely and no data is available |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| San Diego |
| California |
| 92108 |
| United States |
| Compass Clinical Research | San Ramon | California | 94583 | United States |
| Comprehensive Clinical Trials | West Palm Beach | Florida | 33409 | United States |
| Physicians for Women | Cary | North Carolina | 27518 | United States |
| HWC Women's Research Center | Miamisburg | Ohio | 45322 | United States |
| Clinical Trials of Texas/Institute for Women's Health | San Antonio | Texas | 78229 | United States |
| Clinical Trials of Texas/Seven Oaks Women's Center | San Antonio | Texas | 78229 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 18 participants were randomized; study prematurely terminated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Proellex® | Proellex®: one (1) 25 mg capsule daily |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily | Number of participants who experienced 1 or more adverse event. | Posted | Number | Participants | 6 months |
|
|
|
6 months
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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 | Proellex® | Proellex®: one (1) 25 mg capsule daily No data available | 0 | 18 | 16 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seasonal Allergies | Immune system disorders | Systematic Assessment |
| ||
| 1.5 % decrease femur bone density | Investigations | Systematic Assessment |
| ||
| abnormal labs | Investigations | Systematic Assessment |
| ||
| cervical tenderness | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Crying | Nervous system disorders | Systematic Assessment |
| ||
| Cystic Left Ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Decrease in Bone mineral Density | Investigations | Systematic Assessment |
| ||
| Decreased bone Mineral Density in the Lumbar Spine | Investigations | Systematic Assessment |
| ||
| Decreased Libido | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Elevated ALT | Investigations | Systematic Assessment | ALT (Alanine Transaminase) |
| |
| Elevated AST | Investigations | Systematic Assessment | AST (Aspartate Transaminase) |
| |
| exacerbation migraine | Nervous system disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hot Flashes | Vascular disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Irregular Heart Beat | Cardiac disorders | Systematic Assessment |
| ||
| joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Left Cystic Ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Left hip bone mineral density decreased | Investigations | Systematic Assessment |
| ||
| left lower quadrant pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| left ovarian complex cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lumbar Spine Bone Mineral Density Decreased | Investigations | Systematic Assessment |
| ||
| Mood Swings | Nervous system disorders | Systematic Assessment |
| ||
| Right lower quadrant abdomen pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Right ovarian complex cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| right ovarian cyst 1.5cm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Right Paraovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| sinus infection | Infections and infestations | Systematic Assessment |
| ||
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
| ||
| verruca vulgaris | Infections and infestations | Systematic Assessment |
| ||
| weight gain | Investigations | Systematic Assessment |
| ||
| Yeast Infection | Infections and infestations | Systematic Assessment |
| ||
| sexual desire loss | Reproductive system and breast disorders | Systematic Assessment |
| ||
| insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
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.
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C461063 | telapristone acetate |
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