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Completed

NCT Number: NCT00882258

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

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.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • six months or more (immediately prior to Screening visit) without a menstrual period, or
  • prior hysterectomy and/or oophorectomy
  • Subjects with documented endometriosis

Treatment and study plan

12.5 mg Proellex

Drug

12.5 mg Proellex administered orally daily

Other names: CDB-4124, Telapristone acetate

25 mg Proellex

Drug

25 mg Proellex administered orally daily

Other names: CDB-4124, Telapristone acetate

Placebo

Drug

Administered orally daily

Other names: Dummy

Primary outcomes

  1. To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata

    Time frame: 91 days

Secondary outcomes

  1. To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata

    Time frame: 91 days

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 16, 2009
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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