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
Phase 1/Phase 2
18 Years
50 Years
18 Years
50 Years
Not Enrolling
Female
Uterine Leiomyomata
Female
Uterine Leiomyomata
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.
Outcome Time Frame:
90 days
Safety Issue:
Yes
Principal Investigator
Ronald Wiehle, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Repros Therapeutics Inc.
Authority:
United States: Food and Drug Administration
Study ID:
ZN-001
NCT ID:
NCT01069094
Start Date:
July 2004
Completion Date:
January 2005
Related Keywords:
- Uterine Leiomyomata
- Uterine fibroids
- Leiomyoma
- Myofibroma
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