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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Abimbola Famuyide, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01165307
First received: July 9, 2010
Last updated: November 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Menorrhagia
Drug: Estradiol 30 mcg / Levonorgestrel 150 mcg monophasic oral contraceptive pills
Drug: Naproxen sodium pills
Device: Nova Sure Radiofrequency Endometrial Ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Efficacy of Treatment Outcomes [ Time Frame: Measured at 12 months following initial treatment ] [ Designated as safety issue: No ]
    1. Menstrual blood loss (MBL) as measured by pictorial blood loss assessment chart (PBLAC).
    2. Patients' satisfaction rates and health related Quality of Life (using SF-12 and menorrhagia specific questionnaire).
    3. Time to failure of treatment (failure is defined as hysterectomy or ablation using a Cox proportional hazard model).
    4. Hemoglobin and Ferritin levels pre and post-treatment
    5. Severity of dysmenorrhea symptoms (using Dysmenorrhea Score) and Premenstrual Syndrome (using PMS-Diary)


Secondary Outcome Measures:
  • Economic Outcomes [ Time Frame: Measured at 12 months following initial treatment ] [ Designated as safety issue: No ]
    1. Disease-specific direct medical costs
    2. Patient and indirect costs (sanitary product use and lost workdays)
    3. Total costs (direct medical costs, patient costs, as well as indirect costs associated with lost workdays or limited abilities).
    4. Incremental mean cost per quality-adjusted life year gained for ablation compared with medical therapy using a preference based measure of health derived from the SF-12®


Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medical Therapy
Subjects will be prescribed monthly packets of 30-microgram estradiol/150mcg levonorgestrel monophasic oral contraceptive pills (Nordette®). 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).
Drug: Estradiol 30 mcg / Levonorgestrel 150 mcg monophasic oral contraceptive pills
Each packet consists of a fixed dose of 30 mcg estradiol and a 150 mcg 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.
Other Name: (Nordette®)
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)
Other Name: Naprosyn 250 mg tablets
Active Comparator: Radiofrequency Endometrial Ablation
Subjects will undergo radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will be performed per the NovaSure® Instructions for Use (IFU) and 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.
Device: Nova Sure 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.
Other Name: NovaSure

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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165307

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Abimbola Famuyide
Hologic, Inc.
Investigators
Principal Investigator: Abimbola O. Famuyide, MBBS Mayo Clinic
  More Information

No publications provided

Responsible Party: Abimbola Famuyide, Consultant, Assistant Professor of Obstetrics-Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01165307     History of Changes
Other Study ID Numbers: 08-007334-00
Study First Received: July 9, 2010
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Menorrhagia. Heavy Menstrual Bleeding. Endometrial Ablation.

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Naproxen
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Polyestradiol phosphate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014