Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Condition: Menorrhagia
MeSH terms: Menorrhagia
Intervention: Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills; Naproxen sodium pills; NovaSure® Radiofrequency Endometrial Ablation
Intervention description: 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.
Intervention MeSH terms: Naproxen; Levonorgestrel; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Female
Minimum age: 30 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Menorrhagia; Endometrial ablation; Heavy menstrual bleeding

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.
    

Eligibility 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