Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882258

Enrollment

144

Registered

2009-04-16

Start date

2006-03-31

Completion date

2007-03-31

Last updated

2014-07-08

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

Detailed description

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Interventions

DRUG12.5 mg Proellex

12.5 mg Proellex administered orally daily

DRUG25 mg Proellex

25 mg Proellex administered orally daily

DRUGPlacebo

Administered orally daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound. * Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain

Exclusion criteria

* Post-menopausal women, as defined as one or more of the following: 1. six months or more (immediately prior to Screening visit) without a menstrual period, or 2. prior hysterectomy and/or oophorectomy * Subjects with documented endometriosis

Design outcomes

Primary

Measure	Time frame
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata	91 days

Secondary

Measure	Time frame
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata	91 days

Countries

United States

Outcome results

None listed

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