Clinical trial NCT01165307: Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menorrhagia
Keywords: Menorrhagia
Endometrial ablation
Heavy menstrual bleeding
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2010-07-19
Enrollment: 77
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).
timeFrame: Measured at 12 months following initial treatment
Secondary outcomes:
measure: Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
timeFrame: Measured at 12 months following initial treatment
measure: Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )
timeFrame: Measured at 12 months following initial treatment
measure: Hemoglobin at 12 Months
timeFrame: Measured at 12 months following initial treatment
measure: Change in Hemoglobin
timeFrame: baseline, 12 months
measure: Ferritin at 12 Months
timeFrame: Measured at 12 months following initial treatment
measure: Change in Ferritin From Baseline
timeFrame: Measured at 12 months following initial treatment
measure: Direct Medical Costs
timeFrame: Measured at 12 months following initial treatment
measure: Indirect Medical Costs
timeFrame: Measured at 12 months following initial treatment
measure: Bleeding Pattern at 12 Months
timeFrame: Measured at 12 months following initial treatment
measure: Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)
timeFrame: Measured at 12 months following initial treatment
measure: Subject Satisfaction at 12 Months
timeFrame: Measured at 12 months following initial treatment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Abimbola O. Famuyide, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.