A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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 of menorrhagia.

Who is eligible to participate?

Inclusion Criteria: 1. Adult female, ages 30-55, who is pre-menopausal and for whom childbearing is complete 2. Subjective symptom of excessive menstrual loss 3. Normal uterine cavity length (≥ 4cm) with a sound measurement of ≤10cm documented by sonohysterogram or hysteroscopy in the preceding 6 months 4. At least one normal Pap Test and no unexplained abnormal Pap Tests within 6 months of procedure 5. Prior history of permanent sterilization or use of reliable non-hormonal contraception during the 14 month study period or history of vasectomy in partner 6. Freely agree to participate in the study including all study related procedures and evaluations, and document this agreement by signing the informed consent document Exclusion Criteria: 1. Pregnancy or desire for future childbearing 2. Active lower genital infection at the time of procedure 3. Active urinary tract infection at the time of procedure 4. Active pelvic inflammatory disease (PID) or recurrent chronic PID 5. Endometrial neoplasia, determined by endometrial biopsy taken within 12 months of study entry 6. Current or past history of cervical or endometrial cancer 7. Uterine sound measurement greater than 10cm 8. Submucous leiomyoma greater than 2cm or cavity distorting leiomyoma 9. History of myomectomy or classical cesarean section 10. Previous endometrial ablation 11. Oral hormonal treatment in the preceding 3 months, hormone releasing intrauterine contraceptive in the preceding month, or injectable hormone treatment in the preceding 12 months 12. Contraindication to hormonal therapy and non-steroidal anti-inflammatory agents. 13. History of a coagulopathy or endocrinopathy 14. Inability to follow up at 12 months

Last updated:

4/8/2013

NCT ID:

NCT01165307