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

Summary

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.

Conditions

• Menorrhagia

Interventions

DRUG

Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills

Each packet consists of a fixed dose of 30mcg estradiol and a 150mcg dose of levonorgestrel for the first 21 days of the cycle, followed by a 7 day pill free period. Subjects will be instructed to administer the pills orally, starting 5 days after the start of menstrual blood flow, continuing cyclically, thus allowing for withdrawal bleeding after the 21 day pill cycle.

DRUG

Naproxen sodium pills

As an alternative to oral contraceptive pills, subjects may take Naproxen 500 mg with onset of menses, then 250 mg three times daily for the duration of the menses (or maximum of five days)

DEVICE

NovaSure® Radiofrequency Endometrial Ablation

Radiofrequency endometrial ablation is performed in the outpatient surgery department. Subjects receive intravenous medication, determined by the attending anesthesiologist, sufficient to induce conscious sedation during the procedure.

Sponsors & Collaborators

• Hologic, Inc.

  collaborator INDUSTRY

• Abimbola Famuyide

  lead OTHER

Principal Investigators

• Abimbola O. Famuyide, MBBS · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2015-09-30

Completion

2015-10-31

Countries

• United States

Study Locations