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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01069094

Enrollment

Registered

2010-02-17

Start date

2004-07-31

Completion date

2005-01-31

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Leiomyomata

Keywords

Uterine fibroids

Brief summary

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

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

DRUGProgenta

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

DRUGLucron Depot

3.75 mg IM monthly

DRUGPlacebo

Administered as a once daily oral dose for 90 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026