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A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis

Phase 4
30 Years
55 Years
Open (Enrolling)

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Trial Information

A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis

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.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of Treatment Outcomes

Outcome Description:

Menstrual blood loss (MBL) as measured by pictorial blood loss assessment chart (PBLAC). Patients' satisfaction rates and health related Quality of Life (using SF-12 and menorrhagia specific questionnaire). Time to failure of treatment (failure is defined as hysterectomy or ablation using a Cox proportional hazard model). Hemoglobin and Ferritin levels pre and post-treatment Severity of dysmenorrhea symptoms (using Dysmenorrhea Score) and Premenstrual Syndrome (using PMS-Diary)

Outcome Time Frame:

Measured at 12 months following initial treatment

Safety Issue:


Principal Investigator

Abimbola O. Famuyide, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

January 2015

Related Keywords:

  • Menorrhagia
  • Menorrhagia. Heavy Menstrual Bleeding. Endometrial Ablation.
  • Menorrhagia
  • Adenoma



Mayo Clinic Rochester, Minnesota  55905