Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958334
First received: August 11, 2009
Last updated: August 5, 2014
Last verified: August 2014

August 11, 2009
August 5, 2014
September 2006
October 2008   (final data collection date for primary outcome measure)
The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. [ Time Frame: baseline, 14 months (3-4 cycles), 17 months ] [ Designated as safety issue: No ]
An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.
To evaluate the safety of Proellex® administered once daily with an off drug period in between in pre menopausal women with uterine leiomyomata. [ Time Frame: Two, 4 month intervals ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00958334 on ClinicalTrials.gov Archive Site
Change From Baseline of ZPU-003 Ext to 14 Months in Subject's Menstrual Pictograms(Subjects Evaluable for Menorrhagia Only) [ Time Frame: baseline and 14 months ] [ Designated as safety issue: No ]
To evaluate the continuing efficacy of Proellex® for the treatment of pre menopausal women with uterine leiomyomata [ Time Frame: Two, 4 month intervals ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003

ZPU-003 EXT is a 2-year extension study of ZPU-003 to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

ZPU-003 EXT is a 2-year extension study of ZPU-003. The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Fibroids
  • Drug: Proellex®
    25 mg daily (two 12.5 mg capsules)
    Other Names:
    • CDB-4124
    • telapristone acetate
  • Drug: Proellex®
    12.5 mg daily
    Other Names:
    • CDB-4124
    • telapristone acetate
  • Drug: Placebo
    Treatment with no active ingredients
    Other Names:
    • Dummy
    • Sham treatment
  • Experimental: Proellex 25 mg
    Proellex® 12.5 mg capsules twice a day
    Intervention: Drug: Proellex®
  • Experimental: Proellex 12.5 mg
    Proellex® 12.5 mg capsules once a day
    Intervention: Drug: Proellex®
  • Placebo Comparator: Placebo
    capsule once a day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.

Exclusion Criteria:

  • Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
  • Pregnant or breastfeeding.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958334
ZPU-003 Ext
Yes
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
Repros Therapeutics Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP