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Prolonged GnRH Agonist and Add-Back Therapy for Symptomatic Endometriosis

2002; Lippincott Williams & Wilkins; Volume: 99; Issue: 5, Part 1 Linguagem: Inglês

10.1097/00006250-200205000-00008

1873-233X

Eric S. Surrey, Mark D. Hornstein,

Pregnancy-related medical research

In Brief OBJECTIVE To assess post-treatment effects in endometriosis patients of a 12-month course of GnRH agonist alone or with one of three “add-back” regimens. METHODS This is a post-treatment follow-up analysis of a randomized, double-masked, placebo-controlled 52-week trial. All patients had received monthly leuprolide acetate and were randomized to one of four groups: A—daily placebo; B—daily norethindrone acetate 5 mg; C—daily norethindrone acetate 5 mg and conjugated equine estrogens 0.625 mg; and D—daily norethindrone acetate 5 mg and conjugated equine estrogens 1.25 mg. Of 201 patients enrolled in the initial trial, 123 completed at least 280 days of therapy and entered the follow-up period. Physical findings and symptoms were quantified, and lumbar spine bone mineral density was determined at intervals for up to 12 and 24 months post-therapy. RESULTS Symptom and pelvic examination scores remained significantly below baseline for at least 8 months after completion of therapy for all four groups (P < .05). Findings were not affected by endometriosis scores noted on screening laparoscopy. Mean bone mineral density values remained at or above baseline in all add-back groups. The significant mean loss in bone density in group A during therapy reversed slowly and had not returned to baseline at the final follow-up visit (P < .001). CONCLUSION GnRH agonist and norethindrone acetate alone or combined with low-dose conjugated equine estrogens administered to symptomatic endometriosis patients for 12 months provides extended pain relief and bone mineral density preservation after completion of therapy. Pain relief and bone mineral density preservation are maintained after completion of a 12-month course of GnRH agonist with add-back therapy for symptomatic endometriosis.