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

Uterine Leiomyomata Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069094
• Other study ID #: ZN-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 12, 2010
• Last updated: June 27, 2014
• Start date: July 2004
• Est. completion date: January 2005

Study information

• Verified date: June 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyomata

Intervention

Drug:
• Progenta
12.5 mg, administered as a once daily oral dose for 90 days.
• Progenta
25 mg, administered as a once daily oral dose for 90 days.
• Progenta
50 mg, administered as a once daily oral dose for 90 days.
• Lucron Depot
3.75 mg IM monthly
• Placebo
Administered as a once daily oral dose for 90 days.

Locations

Country	Name	City	State
Poland	Medical University /MTZ Clinical Research Sp.zo.o.	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.		90 days	Yes
Secondary	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	Yes