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

A

Abimbola Famuyide

Status and phase

Completed
Phase 4

Conditions

Menorrhagia

Treatments

Drug: Naproxen sodium pills
Device: NovaSure® Radiofrequency Endometrial Ablation
Drug: Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01165307
08-007334

Details and patient eligibility

About

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.

Full 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.

Enrollment

77 patients

Sex

Female

Ages

30 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

77 participants in 2 patient groups

Medical Therapy
Active Comparator group
Description:
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).
Treatment:
Drug: Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills
Drug: Naproxen sodium pills
Radiofrequency Endometrial Ablation
Active Comparator group
Description:
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.
Treatment:
Device: NovaSure® Radiofrequency Endometrial Ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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