title: Subcutaneous injection of depot medroxyprogesterone acetate compared with leuprolide acetate in the treatment of endometriosis-associated pain.
abstract: OBJECTIVE
  To compare the efficacy and safety of SC depot medroxyprogesterone acetate (DMPA-SC 104) with that of leuprolide acetate in treatment of endometriosis.
  
  
  METHODS
  Phase 3, multicenter, randomized, evaluator-blinded, comparator-controlled trial.
  
  
  METHODS
  Clinical trial sites in Canada and United States.
  
  
  METHODS
  Two hundred seventy-four women with surgically diagnosed endometriosis.
  
  
  METHODS
  Intramuscular injections of DMPA-SC (104 mg) or leuprolide acetate (11.25 mg), given every 3 months for 6 months, with 12 months of posttreatment follow-up.
  
  
  METHODS
  Reduction in five endometriosis symptoms or signs (dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, pelvic induration); change in bone mineral density (BMD), hypoestrogenic symptoms, bleeding, and weight.
  
  
  RESULTS
  The depot medroxyprogesterone acetate given SC was statistically equivalent to leuprolide in reducing four of five endometriosis symptoms or signs at the end of treatment (month 6) and in reducing all five symptoms after 12 months' follow-up (month 18). Patients in the DMPA-SC 104 group showed significantly less BMD loss than did leuprolide patients at month 6, with scores returning to baseline at 12 months' follow-up. No statistically significant differences in median weight changes were observed between groups. Compared with leuprolide, DMPA-SC 104 was associated with fewer hypoestrogenic symptoms but more irregular bleeding.
  
  
  CONCLUSIONS
  Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain, with less impact on BMD and fewer hypoestrogenic side effects but more bleeding.
authors.affiliation: University of Colorado Health Sciences Center, Aurora, Colorado 80045, USA. william.schlaff@uchsc.edu
authors.forename: William D
authors.initials: WD
authors.lastname: Schlaff
authors.forename: Sandra Ann
authors.initials: SA
authors.lastname: Carson
authors.forename: Anthony
authors.initials: A
authors.lastname: Luciano
authors.forename: Doug
authors.initials: D
authors.lastname: Ross
authors.forename: Agneta
authors.initials: A
authors.lastname: Bergqvist
mesh_terms: D000328:Adult; D015519:Bone Density / Q000187:drug effects; D003692:Delayed-Action Preparations; D004715:Endometriosis / Q000150:complications* / Q000503:physiopathology; D004967:Estrogens / Q000172:deficiency; D005260:Female; D005483:Flushing / Q000503:physiopathology; D006801:Humans; D007279:Injections, Subcutaneous; D016729:Leuprolide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D010166:Palliative Care; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000139:chemically induced
chemical_list: D003692:Delayed-Action Preparations; D004967:Estrogens; D017258:Medroxyprogesterone Acetate; D016729:Leuprolide