Contraceptive efficacy and safety of DMPA-SC

Area of Science:

• Reproductive Health
• Contraception
• Pharmacology

Background:

• Depo-Provera intramuscular (IM) injection is a widely used long-acting injectable contraceptive.
• A new low-dose subcutaneous formulation, DMPA-SC, has been developed to offer an alternative administration route.
• Assessing the efficacy, safety, and patient experience of DMPA-SC is crucial for expanding contraceptive options.

Purpose of the Study:

• To evaluate the contraceptive efficacy, safety, and patient satisfaction of DMPA-SC administered subcutaneously every 3 months.
• To compare the performance of DMPA-SC with the established Depo-Provera IM injection.
• To determine the suitability of DMPA-SC as a long-acting reversible contraceptive (LARC) option.

Main Methods:

• Two large, open-label, Phase 3 clinical studies were conducted.
• Participants received DMPA-SC 104 mg/0.65 mL every 12-13 weeks.
• Data collected included contraceptive efficacy (pregnancies), adverse events, and patient-reported outcomes over 1 year.

Main Results:

• Zero pregnancies were reported across 16,023 woman-cycles of exposure to DMPA-SC.
• The efficacy and safety profile of DMPA-SC was found to be equivalent to Depo-Provera IM.
• DMPA-SC was well-tolerated, with adverse events comparable to the IM formulation, including in overweight/obese women.

Conclusions:

• DMPA-SC is a highly effective and safe subcutaneous contraceptive injection.
• It provides an immediate onset of action and is equivalent to Depo-Provera IM.
• DMPA-SC represents a new, convenient, and effective long-acting reversible contraceptive choice for women.