Back to resultsA Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Primary Purpose
Uterine Leiomyomata
Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Progenta
Progenta
Progenta
Lucron Depot
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Leiomyomata focused on measuring Uterine fibroids
Eligibility 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
Sites / Locations
- Medical University /MTZ Clinical Research Sp.zo.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
progenta 12.5 mg
progenta 25 mg
progenta 50 mg
Lucron Depot
placebo
Arm Description
Progenta (CDB-4124) 12.5 mg capsule
Progenta (CDB-4124) 25 mg capsule
Progenta (CDB-4124) 50 mg capsule
Lucron Depot, Leuprolide acetate for depot suspension
Placebo capsule
Outcomes
Primary Outcome Measures
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
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.
Full Information
NCT ID
NCT01069094
First Posted
February 12, 2010
Last Updated
June 27, 2014
Sponsor
Repros Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01069094
Brief Title
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyomata
Keywords
Uterine fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
progenta 12.5 mg
Arm Type
Experimental
Arm Description
Progenta (CDB-4124) 12.5 mg capsule
Arm Title
progenta 25 mg
Arm Type
Experimental
Arm Description
Progenta (CDB-4124) 25 mg capsule
Arm Title
progenta 50 mg
Arm Type
Experimental
Arm Description
Progenta (CDB-4124) 50 mg capsule
Arm Title
Lucron Depot
Arm Type
Active Comparator
Arm Description
Lucron Depot, Leuprolide acetate for depot suspension
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Intervention Type
Drug
Intervention Name(s)
Progenta
Other Intervention Name(s)
CDB-4124, Telapristone acetate
Intervention Description
12.5 mg, administered as a once daily oral dose for 90 days.
Intervention Type
Drug
Intervention Name(s)
Progenta
Other Intervention Name(s)
CDB-4124, Telapristone acetate
Intervention Description
25 mg, administered as a once daily oral dose for 90 days.
Intervention Type
Drug
Intervention Name(s)
Progenta
Other Intervention Name(s)
CDB-4124
Intervention Description
50 mg, administered as a once daily oral dose for 90 days.
Intervention Type
Drug
Intervention Name(s)
Lucron Depot
Other Intervention Name(s)
leuprolide acetate for depot suspension
Intervention Description
3.75 mg IM monthly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as a once daily oral dose for 90 days.
Primary Outcome Measure Information:
Title
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Wiehle, PhD
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Medical University /MTZ Clinical Research Sp.zo.o.
City
Warsaw
ZIP/Postal Code
02-106
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
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