Clinical trial · Observational
Questionnaire Study to Assess Quality of Life After Treatment of Fibroids
Outcome From Fibroid Therapies: A Comparison With Normal Controls
NCT00390494CI-TRIAL-00001557unknownClinicalTrials.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 purpose of this study is to determine the change in symptoms and health-related quality of life in patients undergoing treatment for fibroids. Results from the questionnaire will be compared with results obtained from patients who do not have fibroids in order to determine a score range that differentiates these two groups.
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 |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hysterectomy | Procedure | — | UNRESOLVED |
| Myomectomy | Procedure | — | UNRESOLVED |
| Uterine Fibroid Embolization | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Fibroid Treatment Group * Pre-menopausal * Between the ages of 35 and 50, inclusive * Scheduled to undergo hysterectomy, myomectomy, or uterine fibroid embolization for treatment of uterine fibroids at one of the participating institutions * Willing to provide written informed consent * Able to speak and read English Inclusion Criteria: Normal Control Group (patients not diagnosed with fibroids) * Pre-menopausal * Between the ages of 35 and 50, inclusive * Normal gynecologic examination at time of enrollment with regular menstrual cycle at the time of enrollment * Willing to provide written informed consent * Able to read and speak English Exclusion Criteria: Fibroid Treatment Group * Currently pregnant * Cognitive impairment that would interfere with completing the questionnaire * Severe psychiatric co-morbidity * Co-morbid or life-threatening condition with life expectancy to be less than 1 year * Active duty military healthcare beneficiary Exclusion Criteria: Normal Control Group * Currently pregnant * Presence of other gynecologic-related diseases (e.g. endometriosis, pelvic inflammatory disease) * Cognitive impairment that would interfere with completing the questionnaire * Severe psychiatric co-morbidity * Co-morbid or life-threatening condition with life expectancy to be less than 1 year * Active duty military healthcare beneficiary
References
Publications (1)
- DERIVEDSpies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes from leiomyoma therapies: comparison with normal controls. Obstet Gynecol. 2010 Sep;116(3):641-652. doi: 10.1097/AOG.0b013e3181ed36b3. PMID 20733447