Clinical trial · Interventional
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
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
NCT01069094CI-TRIAL-00014969completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Leiomyomata | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lucron Depot | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Progenta | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- progenta 12.5 mg
- description
- Progenta (CDB-4124) 12.5 mg capsule
- interventionNames
- Drug: Progenta
- type
- EXPERIMENTAL
- label
- progenta 25 mg
- description
- Progenta (CDB-4124) 25 mg capsule
- interventionNames
- Drug: Progenta
- type
- EXPERIMENTAL
- label
- progenta 50 mg
- description
- Progenta (CDB-4124) 50 mg capsule
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.