Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia (iTOM)
Menorrhagia
About this trial
This is an interventional treatment trial for Menorrhagia focused on measuring Menorrhagia, Endometrial ablation, Heavy menstrual bleeding
Eligibility Criteria
Inclusion Criteria:
- Adult female, ages 30-55, who is pre-menopausal and for whom childbearing is complete
- Subjective symptom of excessive menstrual loss
- Normal uterine cavity length (≥ 4cm) with a sound measurement of ≤10cm documented by sonohysterogram or hysteroscopy in the preceding 6 months
- At least one normal Pap Test and no unexplained abnormal Pap Tests within 6 months of procedure
- Prior history of permanent sterilization or use of reliable non-hormonal contraception during the 14 month study period or history of vasectomy in partner
- 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:
- Pregnancy or desire for future childbearing
- Active lower genital infection at the time of procedure
- Active urinary tract infection at the time of procedure
- Active pelvic inflammatory disease (PID) or recurrent chronic PID
- Endometrial neoplasia, determined by endometrial biopsy taken within 12 months of study entry
- Current or past history of cervical or endometrial cancer
- Uterine sound measurement greater than 10cm
- Submucous leiomyoma greater than 2cm or cavity distorting leiomyoma
- History of myomectomy or classical cesarean section
- Previous endometrial ablation
- 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
- Contraindication to hormonal therapy and non-steroidal anti-inflammatory agents.
- History of a coagulopathy or endocrinopathy
- Inability to follow up at 12 months
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Medical Therapy
Radiofrequency Endometrial Ablation
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.