Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Rochester, Minnesota 55905


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.


Study summary:

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.


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


NCT ID:

NCT01165307


Primary Contact:

Principal Investigator
Abimbola O. Famuyide, MBBS
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.