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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

Page last updated: August 23, 2015

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