Trial | NCT01069094  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    leuprolide progenta ...

  • Study Participants

    29
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
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 Started
Jul 31
2004
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Jun 30
2014
Estimate

Drug Progenta

12.5 mg, administered as a once daily oral dose for 90 days.

  • Other names: CDB-4124, Telapristone acetate

Drug Progenta

25 mg, administered as a once daily oral dose for 90 days.

  • Other names: CDB-4124, Telapristone acetate

Drug Progenta

50 mg, administered as a once daily oral dose for 90 days.

  • Other names: CDB-4124

Drug Lucron Depot

3.75 mg IM monthly

  • Other names: leuprolide acetate for depot suspension

Drug Placebo

Administered as a once daily oral dose for 90 days.

progenta 12.5 mg Experimental

Progenta (CDB-4124) 12.5 mg capsule

progenta 25 mg Experimental

Progenta (CDB-4124) 25 mg capsule

progenta 50 mg Experimental

Progenta (CDB-4124) 50 mg capsule

Lucron Depot Active Comparator

Lucron Depot, Leuprolide acetate for depot suspension

placebo Placebo Comparator

Placebo capsule

Criteria 

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
No Results Posted