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Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study

A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00958412
Enrollment
18
Registered
2009-08-13
Start date
2009-02-28
Completion date
2009-08-31
Last updated
2019-02-12

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

Conditions

Endometriosis

Keywords

Endometriosis, Pelvic pain, Oral progesterone blocker

Brief summary

ZPE-201 Extension of treatment

Detailed description

This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Interventions

DRUGProellex®

one (1) 25 mg capsule daily

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 48 Years
Healthy volunteers
No

Inclusion criteria

* Only subjects treated in the ZPE-201 study will be allowed to enter the extension study. * Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.

Exclusion criteria

* All other subjects

Design outcomes

Primary

MeasureTime frameDescription
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily6 monthsNumber of participants who experienced 1 or more adverse event.

Countries

United States

Participant flow

Participants by arm

ArmCount
Proellex®
Proellex®: one (1) 25 mg capsule daily
18
Total18

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyStudy prematurely terminated18

Baseline characteristics

CharacteristicProellex®
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
18 Participants
Sex: Female, Male
Female
18 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
16 / 18
serious
Total, serious adverse events
0 / 18

Outcome results

Primary

To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily

Number of participants who experienced 1 or more adverse event.

Time frame: 6 months

ArmMeasureValue (NUMBER)
Proellex®To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily16 Participants

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