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Completed

NCT Number: NCT01069094

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

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

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Key information

Conditions

Uterine Leiomyomata Connective Tissue Diseases Leiomyoma Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical University /MTZ Clinical Research Sp.zo.o.

Warsaw, 02-106, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progenta

Drug

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

Other names: CDB-4124, Telapristone acetate

Lucron Depot

Drug

3.75 mg IM monthly

Other names: leuprolide acetate for depot suspension

Placebo

Drug

Administered as a once daily oral dose for 90 days.

Primary outcomes

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

    Time frame: 90 days

Secondary outcomes

  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.

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 17, 2010
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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