Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia

Condition(s) targeted: Menorrhagia

Intervention: Estradiol 30 mcg / Levonorgestrel 150 mcg monophasic oral contraceptive pills (Drug); Naproxen sodium pills (Drug); Nova Sure Radiofrequency Endometrial Ablation (Device)

Phase: Phase 4

Status: Recruiting

Sponsored by: Abimbola Famuyide

Official(s) and/or principal investigator(s):
Abimbola O. Famuyide, MBBS, Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Maureen A. Lemens, BSN, Phone: 507-293-1487, Email: lemens.maureen@mayo.edu

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy of Treatment Outcomes

Secondary outcome: Economic Outcomes

Detailed description: 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.

Minimum age: 30 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

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

Maureen A. Lemens, BSN, Phone: 507-293-1487, Email: lemens.maureen@mayo.edu

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Maureen Lemens, BSN, Phone: 507-293-1487, Email: lemens.maureen@mayo.edu
Abimbola O. Famuyide, MBBS, Principal Investigator

Starting date: August 2009
Last updated: October 4, 2012