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Introduction
Since 2004, a micronised formulation of depo-medroxyprogesterone acetate (DMPA) that is delivered as a subcutaneous injection has been available. It is currently in clinical use in the USA and in nine countries throughout Europe.1 As of March 2013 this product is being marketed in the UK as Sayana® Press (Pfizer, UK). The indications and contraindications for the use of subcutaneous depo-medroxyprogesterone acetate (DMPA-SC) are the same as for the intramuscular preparation (DMPA-IM, Depo Provera®).1 Although the total dose of DMPA is 30% lower with the SC compared to the IM preparation (104 vs 150 mg), the efficacy and effect on the return of fertility are no different from the IM preparation2 ,3 (Table 1).
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Pharmacokinetics
Compared to DMPA-IM, there is a slower rate of absorption of DMPA-SC with lower peak serum medroxyprogestrone acetate (MPA) concentrations providing a long duration of effect. Serum MPA levels still remain above the threshold for inhibition of ovulation for 3 months.2 Based upon this, the recommended injection interval for DMPA-SC is 13±1 weeks.1 The median time to return of ovulation after DMPA-SC is consistent with that for DMPA-IM; and at 12 months post-injection, studies show that ovulation will have resumed in 97% of subjects.2 Trough concentrations of DMPA-SC are not significantly different between injections given on the anterior abdominal wall or anterior thigh, suggesting that the injection site does not affect the contraceptive efficacy.2
Safety and efficacy
Two large Phase III international trials (open, non-comparative) conducted in North and South America and Europe/Asia assessed the 1-year contraceptive efficacy, safety and user satisfaction of DMPA-SC.3 There were no pregnancies observed in over 1700 women and over 16 000 woman-cycles of exposure to DMPA-SC. Importantly, more …
Footnotes
Competing interests The author received an investigator-initiated research grant from Pfizer to conduct the study of self-administration of DMPA-SC and has recently been member of an advisory group on this product.
Provenance and peer review Commissioned; externally peer reviewed.
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