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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