Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
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.