Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills; Naproxen sodium pills; NovaSure® Radiofrequency Endometrial Ablation
Intervention type(s): Drug; Drug; Device
Intervention description(s): 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.; 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); 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.
Other intervention name(s): Nordette®; Naprosyn 250 mg tablets
Intervention MeSH terms: Naproxen; Levonorgestrel; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menorrhagia; Endometrial ablation; Heavy menstrual bleeding