NCT01739621

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

1.6 years

First QC Date

November 29, 2012

Last Update Submit

April 15, 2014

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (2)

  • Bleeding Days

    Number of days of recorded vaginal bleeding and bleeding intensity

    4 months

  • UFS-QOL

    Improvements in quality of life assessed using the UFS-QOL

    4 months

Study Arms (2)

Proellex 12 mg

EXPERIMENTAL

Telapristone acetate, 1 vaginally inserted capsule, once a day, for 4 months

Drug: Proellex 12 mg

Proellex 24 mg

EXPERIMENTAL

Telapristone acetate, 1 vaginally inserted capsule, twice a day, for 4 months

Drug: Proellex 24 mg

Interventions

Proellex 12 mgDRUG
Also known as: telapristone acetate
Proellex 12 mg
Proellex 24 mgDRUG
Also known as: telapristone acetate
Proellex 24 mg

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have a negative pregnancy test at the Baseline visit
  • Subject has successfully completed ZPV-200 and demonstrated a return of menses

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Leiomyoma

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04