Clinical trial · Interventional
Safety of Treatment of Uterine Fibroids With Asoprisnil
A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
NCT00156208CI-TRIAL-00001488completedPhase 3ClinicalTrials.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)
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Menorrhagia | — | UNRESOLVED | — |
| Metrorrhagia | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asoprisnil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Asoprisnil
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: Asoprisnil
Primary outcomes (1)
- measure
- Long Term Safety
- timeFrame
- Throughout 18 month treatment period
Secondary outcomes (11)
- measure
- Cumulative and incremental amenorrhea rates.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment * Otherwise good health * Premenopausal based on Estrogen and Follicle Stimulating Hormone levels * Agrees to double-barrier method of contraception * Adequate endometrial biopsy with no significant histological disorder Exclusion Criteria: * Any abnormal lab or procedure result(s) the study-doctor considers important * History of a blood-clotting disorder * Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away * Significant gynecological disorder, such as endometrial polyp
References
Publications (0)
Data not yet available
No reference posted for this study.