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Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739621
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):
Repros Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Proellex 12 mg Drug: Proellex 24 mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bleeding Days [ Time Frame: 4 months ]
    Number of days of recorded vaginal bleeding and bleeding intensity

  2. UFS-QOL [ Time Frame: 4 months ]
    Improvements in quality of life assessed using the UFS-QOL

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Additional Information:
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Responsible Party: Repros Therapeutics Inc. Identifier: NCT01739621    
Other Study ID Numbers: ZPV-200EXT
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases