Status:
COMPLETED
Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Lead Sponsor:
Abimbola Famuyide
Collaborating Sponsors:
Hologic, Inc.
Conditions:
Menorrhagia
Eligibility:
FEMALE
30-55 years
Phase:
PHASE4
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 mana...
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 glob...
Eligibility Criteria
Inclusion
- Adult female, ages 30-55, who is pre-menopausal and for whom childbearing is complete
- Subjective symptom of excessive menstrual loss
- Normal uterine cavity length (≥ 4cm) with a sound measurement of ≤10cm documented by sonohysterogram or hysteroscopy in the preceding 6 months
- At least one normal Pap Test and no unexplained abnormal Pap Tests within 6 months of procedure
- Prior history of permanent sterilization or use of reliable non-hormonal contraception during the 14 month study period or history of vasectomy in partner
- 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
- Pregnancy or desire for future childbearing
- Active lower genital infection at the time of procedure
- Active urinary tract infection at the time of procedure
- Active pelvic inflammatory disease (PID) or recurrent chronic PID
- Endometrial neoplasia, determined by endometrial biopsy taken within 12 months of study entry
- Current or past history of cervical or endometrial cancer
- Uterine sound measurement greater than 10cm
- Submucous leiomyoma greater than 2cm or cavity distorting leiomyoma
- History of myomectomy or classical cesarean section
- Previous endometrial ablation
- 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
- Contraindication to hormonal therapy and non-steroidal anti-inflammatory agents.
- History of a coagulopathy or endocrinopathy
- Inability to follow up at 12 months
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01165307
Start Date
August 1 2009
End Date
October 1 2015
Last Update
January 20 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905