Jenny Sadler Gallagher1, Stacey A Missmer2, Mark D Hornstein3, Marc R Laufer4, Catherine M Gordon5, Amy D DiVasta6. 1. Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, Massachusetts; Division of Adolescent and Young Adult Medicine, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: jenny.sadler@childrens.harvard.edu. 2. Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, Massachusetts; Division of Adolescent and Young Adult Medicine, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts; Department of Obstetrics, Gynecology, and Reproductive Biology, College of Human Medicine, Michigan State University, Grand Rapids, Michigan. 3. Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, Massachusetts; Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. 4. Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, Massachusetts; Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts. 5. Division of Adolescent and Transition Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio. 6. Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, Massachusetts; Division of Adolescent and Young Adult Medicine, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.
Abstract
STUDY OBJECTIVE: 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. DESIGN: Follow-up questionnaire sent in 2016 to patients who participated in a drug trial between 2008 and 2012. SETTING:Tertiary care center in Boston, Massachusetts. PARTICIPANTS: Female adolescents with surgically confirmed endometriosis (n = 51) who enrolled in a GnRHa plus add-back trial as adolescents. INTERVENTIONS:Leuprolide depot 11.25 mg intramuscular injection every 3 months, plus oral norethindrone acetate 5 mg daily or oralnorethindrone acetate 5 mg daily and oralconjugated equine estrogens 0.625 mg daily. MAIN OUTCOME MEASURES: Side effects during and after treatment, irreversible side effects, changes in pain, overall satisfaction. RESULTS: The response rate was 61% (25 of 41; 10 subjects could not be located). Almost all (24 of 25) reported side effects during treatment; 80% (16 of 21) reported side effects lasting longer than 6 months after stopping treatment. Almost half (9 of 20) reported side effects they considered irreversible, including memory loss, insomnia, and hot flashes. Despite side effects, participants rated GnRHa plus add-back as the most effective hormonal medication for treating endometriosis pain; two-thirds (16 of 25) would recommend it to others. More participants who received a modified 2-drug add-back regimen vs standard 1-drug add-back would recommend GnRHa and believed it was the most effective hormonal medication. CONCLUSION: Subjects believed that GnRHa used with add-back was effective and would recommend it to others, despite significant side effects. Those who received 2-drug add-back reported more success than those who received standard add-back. A subset of patients reported side effects they consider to be irreversible.
RCT Entities:
STUDY OBJECTIVE: 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. DESIGN: Follow-up questionnaire sent in 2016 to patients who participated in a drug trial between 2008 and 2012. SETTING: Tertiary care center in Boston, Massachusetts. PARTICIPANTS: Female adolescents with surgically confirmed endometriosis (n = 51) who enrolled in a GnRHa plus add-back trial as adolescents. INTERVENTIONS: Leuprolide depot 11.25 mg intramuscular injection every 3 months, plus oral norethindrone acetate 5 mg daily or oral norethindrone acetate 5 mg daily and oral conjugated equine estrogens 0.625 mg daily. MAIN OUTCOME MEASURES: Side effects during and after treatment, irreversible side effects, changes in pain, overall satisfaction. RESULTS: The response rate was 61% (25 of 41; 10 subjects could not be located). Almost all (24 of 25) reported side effects during treatment; 80% (16 of 21) reported side effects lasting longer than 6 months after stopping treatment. Almost half (9 of 20) reported side effects they considered irreversible, including memory loss, insomnia, and hot flashes. Despite side effects, participants rated GnRHa plus add-back as the most effective hormonal medication for treating endometriosis pain; two-thirds (16 of 25) would recommend it to others. More participants who received a modified 2-drug add-back regimen vs standard 1-drug add-back would recommend GnRHa and believed it was the most effective hormonal medication. CONCLUSION: Subjects believed that GnRHa used with add-back was effective and would recommend it to others, despite significant side effects. Those who received 2-drug add-back reported more success than those who received standard add-back. A subset of patients reported side effects they consider to be irreversible.
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