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TerminatedNCT01069120Updated Aug 21, 2014Results posted

Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

A Phase 3 interventional study of Proellex and Proellex in Uterine Fibroids, sponsored by Repros Therapeutics Inc.. Terminated at 4 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-21.

Sponsored by Repros Therapeutics Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated
Repros stopped study due to safety and FDA placed study on hold
Phase
Phase 3
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Safety and efficacy study of 25 and 50 mg doses of Proellex

Read the detailed description

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

02

Conditions studied

  • Uterine Fibroids

Keywords

  • Uterine Fibroids
03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's enrollment of 27 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
  • Subject has a menstrual cycle lasting from 20 to 40 days.
  • Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion criteria

Exclusion Criteria:

  • Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
  • Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    50 mg Proellex®

    2, 25 mg capsules

    Drug: Proellex

  • Active comparator
    25 mg Proellex®

    1, 25 mg capsule

    Drug: Proellex

Interventions

  • DrugProellex

    2, 25 mg capsules once per day

    Also known as: CDB-4124

  • DrugProellex

    1, 25 mg capsule once per day

    Also known as: CDB-4124

06

What researchers measure

Primary outcomes

  1. To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)

    Time frame: During two 4 month treatment periods

07

Results

Posted Aug 21, 2014
Limitations and caveats
The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

Participant flow

Participant flow — Overall Study
MilestoneProellex®
Started27
Completed0
Not completed27
Withdrew: Study prematurely terminated27

Outcome measures

PrimaryTo Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
Time frame:
During two 4 month treatment periods

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
50 mg Proellex®———
25 mg Proellex®———

Baseline characteristics

Study prematurely terminated

Age, Categorical
Age, Categorical(Participants)50 mg Proellex®25 mg Proellex®Total
Sex: Female, Male
Sex: Female, Male(Participants)50 mg Proellex®25 mg Proellex®Total
Region of Enrollment
Region of Enrollment(participants)50 mg Proellex®25 mg Proellex®Total
08

Study locations

4 sites
  • Visions Clinical Research
    Boynton Beach, Florida 33472, United States
  • Insignia Clinical Research (Tampa Bay Women's Center)
    Tampa, Florida 33067, United States
  • Advances in Health Inc
    Houston, Texas 77030, United States
  • The Women's Hospital of Texas, Clinical Research Center
    Houston, Texas 77054, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01069120
Lead sponsor
Repros Therapeutics Inc.
Responsible party
Sponsor
First posted
Feb 17, 2010
Start date
Apr 2009
Primary completion
Aug 2009
Completion
Aug 2009
Results posted
Aug 21, 2014
Last update
Aug 21, 2014

Study contacts

Andre vanAS, PhD, Md
study director · Repros Therapeutics Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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