title: Treatment of Endometriosis with the GnRHa Deslorelin and Add-Back Estradiol and Supplementary Testosterone.
abstract: BACKGROUND
  This randomized, multicenter, open-label clinical trial was intended to generate pilot data on the efficacy and safety of the gonadotropin-releasing hormone agonist (GnRHa) deslorelin (D) with low-dose estradiol ± testosterone (E2  ± T) add-back for endometriosis-related pelvic pain.
  
  
  METHODS
  Women with pelvic pain and laparoscopically confirmed endometriosis were treated with a six-month course of daily intranasal D with concurrent administration of either transdermal E2, intranasal E2, or intranasal E2  + T. Efficacy data included evaluation of dyspareunia, dysmenorrhea, pelvic pain, tenderness, and induration. Cognition and quality of life were also assessed. Safety parameters included assessment of endometrial hyperplasia, bone mineral density (BMD), and hot flashes.
  
  
  RESULTS
  Endometriosis symptoms and signs scores decreased in all treatment arms from a baseline average of 7.4 to 2.5 after 3 months of treatment and 3.4 after 6 months. BMD changes and incidence of hot flashes were minimal, and no endometrial hyperplasia was observed. Patient-reported outcomes showed significant improvement across multiple domains.
  
  
  CONCLUSIONS
  Daily intranasal D with low dose E2  ± T add-back resulted in significant reduction in severity of endometriosis symptoms and signs with few safety signals and minimal hypoestrogenic symptoms that would be expected with the use of a GnRHa alone.
authors.affiliation: Center for Endometriosis Research and Treatment, Department of Reproductive Medicine, UC San Diego, 9500 Gilman Drive, No. 0633, La Jolla, CA 92093-0633, USA.
authors.forename: Sanjay K
authors.initials: SK
authors.lastname: Agarwal
authors.affiliation: Balance Pharmaceuticals, 842 N Las Casas Avenue, Pacific Palisades, CA 90272, USA.
authors.forename: AnnaMarie
authors.initials: A
authors.lastname: Daniels
authors.affiliation: Genesis Center for Clinical Research, 3651 4th Avenue, San Diego, CA 92103, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Drosman
authors.affiliation: Genetics and IVF Institute, 3015 Williams Drive, Fairfax, VA 22031, USA.
authors.forename: Laurence
authors.initials: L
authors.lastname: Udoff
authors.affiliation: Department of Obstetrics and Gynecology, McMaster University, 1280 Main Street West, HSC-3N52D, Hamilton, ON, Canada L8S 4K1.
authors.forename: Warren G
authors.initials: WG
authors.lastname: Foster
authors.affiliation: Department of Preventive Medicine, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.
authors.forename: Malcolm C
authors.initials: MC
authors.lastname: Pike
authors.affiliation: Division of Medical Oncology, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.
authors.forename: Darcy V
authors.initials: DV
authors.lastname: Spicer
authors.affiliation: Division of Medical Oncology, University of Southern California, 1441 Eastlake Avenue, Los Angeles, CA 90033, USA.
authors.forename: John R
authors.initials: JR
authors.lastname: Daniels
mesh_terms: D000328:Adult; D004715:Endometriosis / Q000188:drug therapy* / Q000453:epidemiology; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D013739:Testosterone / Q000008:administration & dosage / Q000627:therapeutic use*; D017329:Triptorelin Pamoate / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D004791:Enzyme Inhibitors; D017329:Triptorelin Pamoate; D013739:Testosterone; D004958:Estradiol; C066438:deslorelin