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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01069094
First received: February 12, 2010
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Uterine Leiomyomata
Drug: Progenta
Drug: Lucron Depot
Drug: Placebo
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: July 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CDB-4124
  • Telapristone acetate
Experimental: progenta 25 mg
Progenta (CDB-4124) 25 mg capsule
Drug: Progenta
25 mg, administered as a once daily oral dose for 90 days.
Other Names:
  • CDB-4124
  • Telapristone acetate
Experimental: progenta 50 mg
Progenta (CDB-4124) 50 mg capsule
Drug: Progenta
50 mg, administered as a once daily oral dose for 90 days.
Other Name: CDB-4124
Active Comparator: Lucron Depot
Lucron Depot, Leuprolide acetate for depot suspension
Drug: Lucron Depot
3.75 mg IM monthly
Other Name: leuprolide acetate for depot suspension
Placebo Comparator: placebo
Placebo capsule
Drug: Placebo
Administered as a once daily oral dose for 90 days.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069094

Locations
Poland
Medical University /MTZ Clinical Research Sp.zo.o.
Warsaw, Poland, 02-106
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Ronald Wiehle, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01069094     History of Changes
Other Study ID Numbers: ZN-001
Study First Received: February 12, 2010
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014