Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Excessive menstrual loss (menorrhagia) is a common condition that affects women of
 reproductive age, and can result in anemia, chronic fatigue and lost wages from work. The
 traditional first line management involves treatment with oral contraceptives or
 non-steroidal anti-inflammatory agents. Many women ultimately undergo hysterectomy, a major
 operative procedure associated with increased costs, loss of feeling of womanhood,
 debilitating complications and on rare occasions, death.

 The newer global endometrial ablation (GEA) devices allow the destruction of the endometrial
 lining, without the removal of the uterus, in an ambulatory surgery setting. GEA offers a
 safe and effective alternative to hysterectomy with minimal risks and without unpleasant
 side-effects.

 Presently, global endometrial ablation is offered as an alternative to hysterectomy, after
 medical intervention has failed. This study will determine the role of global endometrial
 ablation in the initial management of menorrhagia. Women seeking treatment for menorrhagia
 will be randomized to either the medical treatment arm or the global endometrial ablation
 arm.

 This study will be the first to compare clinical efficacy and costs between oral
 contraceptive pills and global endometrial ablation in the initial management of menorrhagia
 and could potentially change the management of menorrhagia and impact millions of women who
 suffer from this condition.
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.
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