Subcutaneous injection of depot medroxyprogesterone acetate compared with leuprolide acetate in the treatment of endometriosis-associated pain.
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.
Schlaff
William D
WD
University of Colorado Health Sciences Center, Aurora, Colorado 80045, USA. william.schlaff@uchsc.edu
Carson
Sandra Ann
SA
Luciano
Anthony
A
Ross
Doug
D
Bergqvist
Agneta
A
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
D003692:Delayed-Action Preparations; D004967:Estrogens; D017258:Medroxyprogesterone Acetate; D016729:Leuprolide