A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis
Goal of study: To evaluate the safety, effectiveness as well as cost- effectiveness of
Global Endometrial Ablation (GEA) as an initial treatment for menorrhagia.
Specific aim #1: To determine if global endometrial ablation (GEA) is more effective than
medical therapy in the initial management of menorrhagia.
Specific aim #2: To determine disease-specific resource utilization and costs associated
with the treatment alternatives and the cost effectiveness of global endometrial ablation
(GEA) compared with medical treatment (oral contraceptive pills) in the initial management
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of Treatment Outcomes
Menstrual blood loss (MBL) as measured by pictorial blood loss assessment chart (PBLAC). Patients' satisfaction rates and health related Quality of Life (using SF-12 and menorrhagia specific questionnaire). Time to failure of treatment (failure is defined as hysterectomy or ablation using a Cox proportional hazard model). Hemoglobin and Ferritin levels pre and post-treatment Severity of dysmenorrhea symptoms (using Dysmenorrhea Score) and Premenstrual Syndrome (using PMS-Diary)
Measured at 12 months following initial treatment
Abimbola O. Famuyide, MBBS
United States: Food and Drug Administration
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