A Phase 2, Multi-Center, Extension Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
This is an open label, extension study of ZPV-200 applicable to multiple study sites.
Subjects will chose to administer 12 mg Proellex vaginal doses once or twice daily (morning
and evening). Total study participation for ZPV-200 EXT may be up to 120 days of drug
treatment separated from ZPV-200 by an off-drug interval and a 30 day follow up visit.
Subjects already enrolled in ZPV-200EXT and the remainder of the subjects who enroll will
have the option of administering 12 mg vaginal capsules once or twice daily. This choice
will be provided to new subjects at Visit 1.
The first 4 subjects who chose to administer 12 mg Proellex twice daily, will have
additional study procedures during the baseline visit and the day after.
Once a subject has selected a dosing regimen the subject must remain on that dose for the
remainder of the study.
All subjects entering the ZPV-200EXT study will have completed the ZPV-200 study and will
complete an off-drug interval prior to the start of their first dosing cycle. In the
off-drug interval, subject must have a menses prior to resumption of the dosing cycle in the
Efficacy measurements will consist of UFS-QOL (uterine fibroid symptom quality of life
survey) sub-scores and total score, and number of bleeding days per drug treatment cycle as
recorded in subject diaries. Fibroid size will be assessed by MRI (magnetic resonance
imaging) at the end of treatment (Visit 5), and changes in size of uterine fibroids will be
compared to MRI results from Visit 2 and Visit 10 of ZPV-200.
Safety measurements for this study will include adverse events (AEs), clinical laboratory
tests, hormone tests, physical examinations (including breast examination and pelvic
examination with PAP smear) and vital signs.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of days of recorded vaginal bleeding and bleeding intensity
United States: Food and Drug Administration