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A Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01069094
First received: February 12, 2010
Last updated: February 16, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


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
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:

MedlinePlus related topics: Menopause
U.S. FDA Resources

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: 1
Progenta (CDB-4124) 12.5 mg capsule
 Drug: Progenta
12.5 mg, administered as a once daily oral dose for 90 days.
Other Name: CDB-4124
Experimental: 2
Progenta (CDB-4124) 25 mg capsule
 Drug: Progenta
25 mg, administered as a once daily oral dose for 90 days.
Other Name: CDB-4124
Experimental: 3
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: 4
Leuprolide acetate for depot suspension
 Drug: Lucron Depot
3.75 mg IM monthly
Other Name: leuprolide acetate for depot suspension
Placebo Comparator: 5
Placebo capsule
 Drug: Placebo
Administered as a once daily oral dose for 90 days.
Other Name: Placebo

  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
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: Ronald Wiehle, PhD, Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01069094     History of Changes
Other Study ID Numbers: ZN-001
Study First Received: February 12, 2010
Last Updated: February 16, 2010
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
Progesterone
Leuprolide
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 19, 2013