A phase 1, randomized, open-label, single-dose relative bioavailability study of upper arm injection of depot medroxyprogesterone acetate comparing pharmacokinetics and hormone indicators of ovulation with anterior thigh and abdomen injection.
Nancy Sherman, Sakambari Tripathy, Isabelle Huyghe et al.
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In 30 seconds
This single-centre, randomized, open-label phase 1 relative bioavailability trial compared one 104 mg subcutaneous dose of depot medroxyprogesterone acetate (DMPA-SC) injected into the upper arm with injection into the abdomen or anterior thigh. The study enrolled 67 healthy, pre-menopausal women aged 18 years or older. Upper-arm administration produced 42% greater MPA AUC and 24% greater C max than the reference sites, while Day 92 trough concentrations were similar (test/reference 95.17%; 90% CI: 73.80, 122.73). No successfully injected participant showed hormonal indications of ovulation after dosing, and no new safety findings were noted.
Key findings
- MPA AUC was 42% greater and C max was 24% greater after upper-arm injection than after reference-site injection.
- Day 92 trough concentrations were similar: test/reference 95.17%; 90% CI: 73.80, 122.73.
- No successfully injected participant showed serum hormone indications of ovulation after drug administration.
- No new adverse safety findings were noted in the upper-arm or reference groups.
Why it matters
The findings suggest that the upper arm may provide an additional administration site for DMPA-SC, with trough exposure and hormonal markers consistent with those observed at currently approved sites. This may broaden administration options, although the evidence comes from a single-dose study and does not establish outcomes with repeated use.
What to keep in mind
The trial was single-centre and assessed only one dose; the abstract reports pharmacokinetic and hormonal indicators rather than contraceptive outcomes during repeated use.