CompletedNot Applicable

PK of Depo SubQ Injected in the Upper Arm

United States26 participantsStarted 2010-05

Plain-language summary

A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: \-

What they're measuring

Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))

Timeframe: 120 days following injection

Tmax (Time to Cmax)

Timeframe: 120 days following injection

AUC 0-91 (Area Under Curve)

Timeframe: first 91 days following injection

MPA Concentration at Day 91 (C91)

Timeframe: day 91 after first injection

MPA Concentration at Day 104 (C104)

Timeframe: day 104 after injection

MPA Concentration at Day 120 (C120)

Timeframe: day 120 after injection

Trial details

NCT IDNCT01143207

SponsorFHI 360

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2013-08-05

View on ClinicalTrials.gov More Contraception trials