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This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment cycles, each with a 16 week active dosing period. Endometriosis pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia (BBSS) as well as use of pain medications, and vaginal bleeding intensity will be recorded using an electronic diary and Visual Analog Scale (VAS) pain assessment will be utilized. All subjects will have completed an Off-Drug Interval (ODI) prior to starting treatment. Visit 1 will be scheduled within a week before the next expected menses (+/- 2 days), following the off-drug interval. Subjects will receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will be followed until menses has returned. During the follow-up period subjects will continue to record study information in the electronic diary. The final follow-up visit will be scheduled after blood flow has stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 mg Proellex | Experimental | 12 mg capsules, orally, once daily for 8 months, including off-drug interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proellex | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Prescription Analgesic Use | Percent change from baseline in use of prescription analgesics comparing the ZPE-202 baseline nominal 28-day menstrual cycle (including menstrual event) to a similar period leading up to the end of treatment in the extension study (Visit 10) | 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72223 | United States | |||
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| Label | URL |
|---|---|
| Sponsor Corporate Website | View source |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C461063 | telapristone acetate |
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| Clearwater |
| Florida |
| 33759 |
| United States |
| Margate | Florida | 33063 | United States |
| Summerville | South Carolina | 29485 | United States |
| Houston | Texas | 77030 | United States |
| Riverton | Utah | 84065 | United States |
| Salt Lake City | Utah | 84124 | United States |
| D000091662 | Genital Diseases |