Long-Term Effects of Gonadotropin-Releasing Hormone Agonists and Add-Back in Adolescent Endometriosis

Abstract

<div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e194">Study Objective</h5> <p id="P2">To explore the potential occurrence of long-term side effects and tolerability of gonadotropin-releasing hormone agonist (GnRHa) plus 2 different add-back regimens in adolescent patients with endometriosis </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e199">Design</h5> <p id="P3">Follow-up questionnaire sent in 2016 to patients who participated in a drug trial between 2008–2012 </p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e204">Setting</h5> <p id="P4">Tertiary care center in Boston, MA.</p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e209">Participants</h5> <p id="P5">Females with surgically confirmed endometriosis (n=51) who enrolled in a GnRHa plus add-back trial as adolescents </p> </div><div class="section"> <a class="named-anchor" id="S5"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e214">Interventions</h5> <p id="P6">Leuprolide depot 11.25 mg intramuscular injection every 3 month, plus oral norethindrone acetate 5 mg daily or oral norethindrone acetate 5 mg daily plus oral conjugated equine estrogens 0.625 mg daily. </p> </div><div class="section"> <a class="named-anchor" id="S6"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e219">Main Outcome Measure(s)</h5> <p id="P7">Side effects during and after treatment, irreversible side effects, changes in pain, overall satisfaction </p> </div><div class="section"> <a class="named-anchor" id="S7"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e224">Results</h5> <p id="P8">The response rate was 61%. Almost all (96%) reported side effects during treatment; 80% reported side effects lasting &gt; 6 months after stopping treatment. Almost half (45%) reported side effects they considered irreversible, including memory loss, insomnia, and hot flashes. Despite side effects, subjects rated GnRHa plus add-back as the most effective hormonal medication for treating endometriosis pain; two thirds (16/25) would recommend it to others. More subjects who received a modified two drug add-back regimen versus standard one drug add-back would recommend GnRHa and felt it was the most effective hormonal medication. </p> </div><div class="section"> <a class="named-anchor" id="S8"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e229">Conclusion</h5> <p id="P9">Subjects felt GnRHa plus add-back was effective and would recommend it to others, despite significant side effects. Those who received two drug add-back reported more success than those who received standard add-back. A subset of patients reported irreversible side effects. </p> </div><div class="section"> <a class="named-anchor" id="S9"> <!-- named anchor --> </a> <h5 class="section-title" id="d6447635e234">Clinical Trial registration</h5> <p id="P10">ClinicalTrials.gov, NCT00474851</p> </div>