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

June 27, 2014 updated by: Repros Therapeutics Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-106
        • Medical University /MTZ Clinical Research Sp.zo.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: progenta 12.5 mg
Progenta (CDB-4124) 12.5 mg capsule
Drug: Progenta
12.5 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • Telapristone acetate
  • CDB-4124
Drug: Progenta
25 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • Telapristone acetate
  • CDB-4124
Drug: Progenta
50 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • CDB-4124
EXPERIMENTAL: progenta 25 mg
Progenta (CDB-4124) 25 mg capsule
Drug: Progenta
12.5 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • Telapristone acetate
  • CDB-4124
Drug: Progenta
25 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • Telapristone acetate
  • CDB-4124
Drug: Progenta
50 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • CDB-4124
EXPERIMENTAL: progenta 50 mg
Progenta (CDB-4124) 50 mg capsule
Drug: Progenta
12.5 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • Telapristone acetate
  • CDB-4124
Drug: Progenta
25 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • Telapristone acetate
  • CDB-4124
Drug: Progenta
50 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • CDB-4124
ACTIVE_COMPARATOR: Lucron Depot
Lucron Depot, Leuprolide acetate for depot suspension
Drug: Lucron Depot
3.75 mg IM monthly
Other Names:
  • leuprolide acetate for depot suspension
PLACEBO_COMPARATOR: placebo
Placebo capsule
Drug: Placebo
Administered as a once daily oral dose for 90 days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (ESTIMATE)

February 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 30, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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