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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01739621
First received: November 29, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.


Condition Intervention Phase
Uterine Fibroids
Drug: Proellex 12 mg
Drug: Proellex 24 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Bleeding Days [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Number of days of recorded vaginal bleeding and bleeding intensity

  • UFS-QOL [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Improvements in quality of life assessed using the UFS-QOL


Estimated Enrollment: 40
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proellex 12 mg
Telapristone acetate, 1 vaginally inserted capsule, once a day, for 4 months
Drug: Proellex 12 mg
Other Name: telapristone acetate
Experimental: Proellex 24 mg
Telapristone acetate, 1 vaginally inserted capsule, twice a day, for 4 months
Drug: Proellex 24 mg
Other Name: telapristone acetate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 47 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01739621     History of Changes
Other Study ID Numbers: ZPV-200EXT
Study First Received: November 29, 2012
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 18, 2014