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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


Phase 2
18 Years
50 Years
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

91 days

Safety Issue:

Yes

Principal Investigator

Andre VanAs, PhD, MD

Investigator Role:

Study Director

Investigator Affiliation:

Repros Therapeutics Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ZPU-003

NCT ID:

NCT00882258

Start Date:

March 2006

Completion Date:

March 2007

Related Keywords:

  • Uterine Fibroids
  • Uterine fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Visions Clinical ResearchBoynton Beach, Florida  33472
Women's Health ResearchPhoenix, Arizona  85015
Alabama Clinical Therapeutics, LlcBirmingham, Alabama  35235
Downtown Women's Health CareDenver, Colorado  80218
Insignia Clinical Research (Tampa Bay Women's Center)Tampa, Florida  33607
SC Clinical Research CenterColumbia, South Carolina  29201
Advances in Health Inc.Houston, Texas  77030
Arizona Wellness Centre for WomenPhoenix, Arizona  85032
Visions Clinical Research TusconTuscon, Arizona  85712
Women's Health Care, Inc.San Diego, California  92123
Medical Centre for Clinical ResearchSan Diego, California  92108
Miami Research Associates, Women's Health StudiesMiami, Florida  33143
Caring for WomenLas Vegas, Nevada  89106
Affiliated Clinical Research, Inc.Las Vegas, Nevada  89128
Obstetrical & Gynecolgical Associates, PA (OGA)Houston, Texas  77054
Women's Clinical Research CentreSeattle, Washington  98105