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

Sponsor
Repros Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01069094
Collaborator
(none)
29
Enrollment
1
Location
5
Arms
6
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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 Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: progenta 12.5 mg

Progenta (CDB-4124) 12.5 mg capsule

Drug: Progenta
12.5 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • CDB-4124
  • Telapristone acetate

    		•
    Experimental: progenta 25 mg

    Progenta (CDB-4124) 25 mg capsule

    Drug: Progenta
    25 mg, administered as a once daily oral dose for 90 days.
    Other Names:
  • CDB-4124
  • Telapristone acetate

    		•
    Experimental: progenta 50 mg

    Progenta (CDB-4124) 50 mg capsule

    Drug: Progenta
    50 mg, administered as a once daily oral dose for 90 days.
    Other Names:
  • CDB-4124

    		•
    Active Comparator: Lucron Depot

    Lucron Depot, Leuprolide acetate for depot suspension

    Drug: Lucron Depot
    3.75 mg IM monthly
    Other Names:
  • leuprolide acetate for depot suspension

    		•
    Placebo Comparator: placebo

    Placebo capsule

    Drug: Placebo
    Administered as a once daily oral dose for 90 days.

    Outcome Measures

    Primary Outcome Measures

    1. Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata. [90 days]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University /MTZ Clinical Research Sp.zo.o. Warsaw Poland 02-106

    Sponsors and Collaborators

    • Repros Therapeutics Inc.

    Investigators

    • Study Director: Ronald Wiehle, PhD, Repros Therapeutics Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Repros Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT01069094
    Other Study ID Numbers:
    • ZN-001
    First Posted:
    Feb 17, 2010
    Last Update Posted:
    Jun 30, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Repros Therapeutics Inc.
    Uterine fibroids
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Leuprolide

    Study Results

    No Results Posted as of Jun 30, 2014