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

Study Overview
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Brief Summary
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A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Detailed Description
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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.

Official Title
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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

Conditions
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Uterine Leiomyomata

Intervention / Treatment
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* Drug: Progenta
* Drug: Progenta
* Drug: Progenta
* Drug: Lucron Depot
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: progenta 12.5 mg<br>Progenta (CDB-4124) 12.5 mg capsule | Drug: Progenta<br>* 12.5 mg, administered as a once daily oral dose for 90 days.<br>* Other names: Telapristone acetate;|
| Experimental: progenta 25 mg<br>Progenta (CDB-4124) 25 mg capsule | Drug: Progenta<br>* 25 mg, administered as a once daily oral dose for 90 days.<br>* Other names: Telapristone acetate;|
| Experimental: progenta 50 mg<br>Progenta (CDB-4124) 50 mg capsule | Drug: Progenta<br>* 50 mg, administered as a once daily oral dose for 90 days.<br>* Other names: CDB-4124;|
| Active Comparator: Lucron Depot<br>Lucron Depot, Leuprolide acetate for depot suspension | Drug: Lucron Depot<br>* 3.75 mg IM monthly<br>* Other names: leuprolide acetate for depot suspension;|
| Placebo Comparator: placebo<br>Placebo capsule | Drug: Placebo<br>* Administered as a once daily oral dose for 90 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine fibroids