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

NCT ID: NCT01165307

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2015-10-31

Brief 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.

Conditions

Menorrhagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical Therapy

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).

Group Type: ACTIVE_COMPARATOR

Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills

Intervention Type: DRUG

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.

Naproxen sodium pills

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

NovaSure® Radiofrequency Endometrial Ablation

Intervention Type: DEVICE

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.

Interventions

Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills

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.

Intervention Type: 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)

Intervention Type: DRUG

NovaSure® 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.

Intervention Type: DEVICE

Other Intervention Names

Nordette®; Naprosyn 250 mg tablets

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hologic, Inc.

INDUSTRY

Sponsor Role: collaborator

Abimbola Famuyide

OTHER

Sponsor Role: lead

Responsible Party

Abimbola Famuyide

Consultant, Assistant Professor of Obstetrics-Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abimbola O. Famuyide, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Famuyide AO, Laughlin-Tommaso SK, Shazly SA, Hall Long K, Breitkopf DM, Weaver AL, McGree ME, El-Nashar SA, Lemens MA, Hopkins MR. Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis. PLoS One. 2017 Nov 15;12(11):e0188176. doi: 10.1371/journal.pone.0188176. eCollection 2017.

Reference Type: DERIVED

PMID: 29141040 (View on PubMed)

Other Identifiers

08-007334

Identifier Type: -

Identifier Source: org_study_id