title: The Effects of Gonadotropin-Releasing Hormone Agonist Combined with Add-Back Therapy on Quality of Life for Adolescents with Endometriosis: A Randomized Controlled Trial.
abstract: OBJECTIVE
  Use of gonadotropin-releasing hormone agonists (GnRHa) to treat endometriosis can cause mood and vasomotor side effects. "Add-back therapy," the combination of low-dose hormones, limits side effects but research is limited to adults. We sought to characterize quality of life (QOL) before treatment and to compare an add-back regimen of norethindrone acetate (NA) with conjugated estrogens (CEE) to NA alone for preventing side effects of GnRHa therapy in female adolescents with endometriosis.
  
  
  METHODS
  Twelve-month double-blind, placebo-controlled trial.
  
  
  METHODS
  Pediatric Gynecology clinic in Boston, Massachusetts.
  
  
  METHODS
  Fifty female adolescents (aged 15-22 years) with surgically confirmed endometriosis initiating treatment with GnRHa.
  
  
  METHODS
  Subjects were randomized to: NA (5 mg/d) with CEE (0.625 mg/d) or NA (5 mg/d) with placebo. All subjects received leuprolide acetate depot every 3 months.
  
  
  METHODS
  The Short Form-36 v2 Health Survey, Beck Depression Inventory II, and Menopause Rating Scale were completed at repeated intervals.
  
  
  RESULTS
  At baseline, subjects reported impaired physical health-related QOL compared with national norms (all P < .0001). Over 12 months, these Short Form-36 v2 scores improved (all P < .05). Subjects receiving NA with CEE showed greater improvements in the pain, vitality, and physical health subscales (Pbetween groups< .05) than those receiving NA alone, as well as better physical functioning (P < .05). There were no changes in depression or menopause-like symptoms in either group.
  
  
  CONCLUSIONS
  Female adolescents with endometriosis initiating GnRHa therapy have impaired QOL. Treatment with GnRHa combined with add-back therapy led to improved QOL, with no worsening of mood or menopausal side effects. NA with CEE was superior to NA alone for improving physical health-related QOL.
authors.affiliation: Division of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts; Boston Center for Endometriosis, Boston, Massachusetts. Electronic address: jenny.sadler@childrens.harvard.edu.
authors.forename: Jenny
authors.initials: J
authors.lastname: Sadler Gallagher
authors.affiliation: Clinical Research Program, Boston Children's Hospital, Boston, Massachusetts.
authors.forename: Henry A
authors.initials: HA
authors.lastname: Feldman
authors.affiliation: University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Natalie A
authors.initials: NA
authors.lastname: Stokes
authors.affiliation: Boston Center for Endometriosis, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts; Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Marc R
authors.initials: MR
authors.lastname: Laufer
authors.affiliation: Boston Center for Endometriosis, Boston, Massachusetts; Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Hornstein
authors.affiliation: Division of Adolescent and Transition Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Gordon
authors.affiliation: Division of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts; Boston Center for Endometriosis, Boston, Massachusetts; Division of Gynecology, Boston Children's Hospital, Boston, Massachusetts.
authors.forename: Amy D
authors.initials: AD
authors.lastname: DiVasta
mesh_terms: D000293:Adolescent; D001900:Boston; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004715:Endometriosis / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D004967:Estrogens / Q000008:administration & dosage; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage*; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077563:Norethindrone Acetate; D010146:Pain / Q000209:etiology / Q000523:psychology; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D007987:Gonadotropin-Releasing Hormone; D000077563:Norethindrone Acetate; D016729:Leuprolide; D009640:Norethindrone
keywords: Add-back therapy; Adolescence; Endometriosis; Gonadotropin releasing hormone agonist; Quality of life