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An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00958893
Enrollment
4
Registered
2009-08-13
Start date
2008-06-30
Completion date
2009-08-31
Last updated
2014-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

Keywords

Uterine fibroids

Brief summary

An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Detailed description

This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Interventions

DRUG25 mg Proellex

one 25 mg capsules

Sponsors

Repros Therapeutics Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion criteria

* All other subjects

Design outcomes

Primary

MeasureTime frame
To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.three 4 month cycles separated by off-drug intervals

Countries

United States

Participant flow

Participants by arm

ArmCount
25 mg Proellex
25 mg Proellex daily
0
Total0

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyStudy prematurely terminated4

Baseline characteristics

Characteristic—
Age, Categorical
<=18 years
— Participants
Age, Categorical
>=65 years
— Participants
Age, Categorical
Between 18 and 65 years
— Participants
Region of Enrollment
United States
— participants
Sex: Female, Male
Female
— Participants
Sex: Female, Male
Male
— Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.

Time frame: three 4 month cycles separated by off-drug intervals

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026