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document
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 ) . 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 .
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Intervention_Pharmacological
Prolonged GnRH agonist
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Intervention_Pharmacological
add-back therapy
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Intervention_Pharmacological
GnRH agonist
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Intervention_Pharmacological
" add-back " regimens
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
leuprolide acetate
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Intervention_Control
placebo
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Intervention_Pharmacological
norethindrone acetate
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Intervention_Pharmacological
C-daily norethindrone acetate
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Intervention_Pharmacological
conjugated equine estrogens
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Intervention_Pharmacological
norethindrone acetate
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Intervention_Pharmacological
conjugated equine estrogens
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Intervention_Pharmacological
GnRH agonist
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Intervention_Pharmacological
norethindrone acetate alone
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Intervention_Pharmacological
low-dose conjugated equine estrogens
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Outcome_Physical
symptomatic endometriosis
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Outcome_Physical
lumbar spine bone mineral density
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Outcome_Physical
Symptom and pelvic examination scores
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Outcome_Physical
endometriosis scores
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Outcome_Physical
Mean bone mineral density values
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Outcome_Physical
loss in bone density
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Outcome_Pain
pain relief
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Outcome_Physical
bone mineral density
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Participant_Condition
symptomatic endometriosis
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Participant_Condition
endometriosis
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Participant_Sample-size
201
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Participant_Sample-size
123
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Participant_Condition
symptomatic endometriosis