Prolonged GnRH agonist and add-back therapy for symptomatic endometriosis: long-term follow-up.
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).


CONCLUSIONS
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.
Surrey
Eric S
ES
Colorado Center for Reproductive Medicine, Englewood, Colorado, USA. esurrey@colocrm.com
Hornstein
Mark D
MD
D000328:Adult; D015519:Bone Density / Q000187:drug effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004715:Endometriosis / Q000188:drug therapy*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage*; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077563:Norethindrone Acetate; D010352:Patient Dropouts; D011446:Prospective Studies
D003692:Delayed-Action Preparations; D004966:Estrogens, Conjugated (USP); D007987:Gonadotropin-Releasing Hormone; D000077563:Norethindrone Acetate; D016729:Leuprolide; D009640:Norethindrone