Clinical trial · Interventional
Treatment of Uterine Fibroids With Asoprisnil(J867)
A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata
NCT00152269CI-TRIAL-00001490completedPhase 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 safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Menorrhagia | — | UNRESOLVED | — |
| Metrorrhagia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asoprisnil | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Asoprisnil
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: Asoprisnil
- type
- PLACEBO_COMPARATOR
- label
- 3
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women * History of regular menstrual cycles (21-42 days) * Diagnosis of uterine fibroid(s) * Abnormal vaginal bleeding associated with uterine fibroids * Otherwise in good health * Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails * Negative pregnancy test * Agrees to Double-barrier method of contraception * Pap smear with no evidence of malignancy or pre-malignant changes * Endometrial biopsy with no significant histological disorder Exclusion Criteria: * Any abnormal lab or procedure result the study-doctor considers important * Severe reaction(s) to or are currently using any hormone therapy * History of osteoporosis or other bone disease * Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months * History of Polycystic Ovary Syndrome or prolactinoma * MRI shows significant gynecologic disorder * Uterine size \> 25 weeks gestation * Hemoglobin \< 8 g/dL at Day -1
References
Publications (2)
- DERIVEDStewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007. PMID 30865281
- DERIVEDLarsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27. PMID 23188490