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

NCT ID: NCT01069094

Last Updated: 2014-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Uterine Leiomyomata

Keywords

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Uterine fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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progenta 12.5 mg

Progenta (CDB-4124) 12.5 mg capsule

Group Type EXPERIMENTAL

Progenta

Intervention Type DRUG

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

progenta 25 mg

Progenta (CDB-4124) 25 mg capsule

Group Type EXPERIMENTAL

Progenta

Intervention Type DRUG

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

progenta 50 mg

Progenta (CDB-4124) 50 mg capsule

Group Type EXPERIMENTAL

Progenta

Intervention Type DRUG

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

Lucron Depot

Lucron Depot, Leuprolide acetate for depot suspension

Group Type ACTIVE_COMPARATOR

Lucron Depot

Intervention Type DRUG

3.75 mg IM monthly

placebo

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as a once daily oral dose for 90 days.

Interventions

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Progenta

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

Intervention Type DRUG

Progenta

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

Intervention Type DRUG

Progenta

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

Intervention Type DRUG

Lucron Depot

3.75 mg IM monthly

Intervention Type DRUG

Placebo

Administered as a once daily oral dose for 90 days.

Intervention Type DRUG

Other Intervention Names

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CDB-4124 Telapristone acetate CDB-4124 Telapristone acetate CDB-4124 leuprolide acetate for depot suspension

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Repros Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Wiehle, PhD

Role: STUDY_DIRECTOR

Repros Therapeutics Inc.

Locations

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

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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ZN-001

Identifier Type: -

Identifier Source: org_study_id