PK of Depo SubQ Injected in the Upper Arm
Information source: FHI 360
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Medroxyprogesterone acetate (Drug)
Phase: N/A
Status: Completed
Sponsored by: FHI 360 Official(s) and/or principal investigator(s): David Archer, MD, Principal Investigator, Affiliation: Eastern Virginia Medical School
Summary
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is
adequate for effective contraception
Clinical Details
Official title: Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))Tmax (Time to Cmax) AUC 0-91 (Area Under Curve) MPA Concentration at Day 91 (C91) MPA Concentration at Day 104 (C104) MPA Concentration at Day 120 (C120)
Detailed description:
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are
adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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:
-
Locations and Contacts
Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School, Norfolk, Virginia 23507, United States
Additional Information
Starting date: May 2010
Last updated: August 5, 2013
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