Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density.
BACKGROUND
A formulation of depot medroxyprogesterone acetate (DMPA) has been developed that allows subcutaneous injection (104 mg/0.65 mL; DMPA-SC) and achieves highly effective contraception with a similar tolerability profile to intramuscular DMPA (150 mg/mL; DMPA-IM).


METHODS
This randomized, evaluator-blinded study was designed to compare efficacy, safety, and user satisfaction in women receiving DMPA-SC (n=266) or DMPA-IM (n=268) for 2 years with an option to continue for a third year. The primary objectives were to evaluate bone mineral density (BMD) changes and contraceptive efficacy after 2 years.


RESULTS
A total of 225 women completed the first 2 years of this study (DMPA-SC, n=116; DMPA-IM, n=109). After 2 years of DMPA use, BMD loss was marginally smaller in the DMPA-SC group than in the DMPA-IM group at both the total hip (-3.3% and -3.6%, respectively) and lumbar spine (-4.3% and -5.0%, respectively). In those women who received DMPA during the third year, there were no statistically significant differences in BMD loss between DMPA-SC and DMPA-IM groups at the end of Year 3. Recovery of BMD was observed in the small subpopulation of women who had discontinued DMPA-SC or DMPA-IM after the second year. The 2-year treatment-failure cumulative pregnancy rate was 0% in the DMPA-SC group and 0.8% (95% confidence interval, 0.00-2.37%) in the DMPA-IM group (life-table method). Adverse events were similar in the two groups except that injection site reactions were more common in the DMPA-SC group.


CONCLUSIONS
DMPA-SC is an effective and well-tolerated contraceptive option, providing comparable efficacy and BMD safety to DMPA-IM.
Kaunitz
Andrew M
AM
Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville, Jacksonville, FL 32209, USA. andrew.kaunitz@jax.ufl.edu
Darney
Philip D
PD
Ross
Douglas
D
Wolter
Kevin D
KD
Speroff
Leon
L
D000293:Adolescent; D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D004958:Estradiol / Q000097:blood; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D008796:Metrorrhagia / Q000139:chemically induced; D017060:Patient Satisfaction; D011247:Pregnancy; D055815:Young Adult
D003271:Contraceptive Agents, Female; D003692:Delayed-Action Preparations; D004958:Estradiol; D017258:Medroxyprogesterone Acetate