N/A
Completed N=26
PK of Depo SubQ Injected in the Upper Arm
Source: ClinicalTrials.gov NCT01143207 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Aug 2013
Primary outcomePrimary: Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) — 0.953 ng/mL
Summary
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) |
0.953 | — |
| PRIMARY Tmax (Time to Cmax) |
8 | — |
| PRIMARY AUC 0-91 (Area Under Curve) |
45.1 | — |
| PRIMARY MPA Concentration at Day 91 (C91) |
0.427 | — |
| PRIMARY MPA Concentration at Day 104 (C104) |
0.366 | — |
| PRIMARY MPA Concentration at Day 120 (C120) |
0.327 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-40
- negative pregnancy test on day of injection
- not wishing to become pregnant in the next 12 months
- at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD)
- body mass index of 18-30
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT01143207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.