- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01739621
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 luteal phase.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have a negative pregnancy test at the Baseline visit
- Subject has successfully completed ZPV-200 and demonstrated a return of menses
Exclusion Criteria:
- Women with abnormally high liver enzymes or liver disease. Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) exceeding 1.5x upper limit normal (ULN AND)total bilirubin exceeding 1.5x ULN at baseline and confirmed on repeat).
- Clinically significant abnormal findings on baseline examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proellex 12 mg
Telapristone acetate, 1 vaginally inserted capsule, once a day, for 4 months
|
Other Names:
|
Experimental: Proellex 24 mg
Telapristone acetate, 1 vaginally inserted capsule, twice a day, for 4 months
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding Days
Time Frame: 4 months
|
Number of days of recorded vaginal bleeding and bleeding intensity
|
4 months
|
UFS-QOL
Time Frame: 4 months
|
Improvements in quality of life assessed using the UFS-QOL
|
4 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZPV-200EXT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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