A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Overview

A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Full Title of Study: “A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2005

Detailed Description

Three doses of Progenta (CDB4124 – 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.

Interventions

  • Drug: Progenta
    • 12.5 mg, administered as a once daily oral dose for 90 days.
  • Drug: Progenta
    • 25 mg, administered as a once daily oral dose for 90 days.
  • Drug: Progenta
    • 50 mg, administered as a once daily oral dose for 90 days.
  • Drug: Lucron Depot
    • 3.75 mg IM monthly
  • Drug: Placebo
    • Administered as a once daily oral dose for 90 days.

Arms, Groups and Cohorts

  • Experimental: progenta 12.5 mg
    • Progenta (CDB-4124) 12.5 mg capsule
  • Experimental: progenta 25 mg
    • Progenta (CDB-4124) 25 mg capsule
  • Experimental: progenta 50 mg
    • Progenta (CDB-4124) 50 mg capsule
  • Active Comparator: Lucron Depot
    • Lucron Depot, Leuprolide acetate for depot suspension
  • Placebo Comparator: placebo
    • Placebo capsule

Clinical Trial Outcome Measures

Primary Measures

  • Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
    • Time Frame: 90 days

Secondary Measures

  • Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.
    • Time Frame: 90 days

Participating in This Clinical Trial

Inclusion Criteria

  • Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound. – Had a regular or steady menstrual cycle lasting from 24 to 36 days. Exclusion Criteria:

  • Post-menopausal – Subject with documented endometriosis

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Repros Therapeutics Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ronald Wiehle, PhD, Study Director, Repros Therapeutics Inc.

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