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

Repros Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Uterine Leiomyomata

Treatments: Drug: Progenta; Drug: Placebo; Drug: Lucron Depot

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069094

ZN-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 5 patient groups, including a placebo group

progenta 12.5 mg

Experimental group

Description:

Progenta (CDB-4124) 12.5 mg capsule

Treatment:

Drug: Progenta

Drug: Progenta

Drug: Progenta

progenta 25 mg

Experimental group

Description:

Progenta (CDB-4124) 25 mg capsule

Treatment:

Drug: Progenta

Drug: Progenta

Drug: Progenta

progenta 50 mg

Experimental group

Description:

Progenta (CDB-4124) 50 mg capsule

Treatment:

Drug: Progenta

Drug: Progenta

Drug: Progenta

Lucron Depot

Active Comparator group

Description:

Lucron Depot, Leuprolide acetate for depot suspension

Treatment:

Drug: Lucron Depot

placebo

Placebo Comparator group

Description:

Placebo capsule

Treatment:

Drug: Placebo