Status:

COMPLETED

PK of Depo SubQ Injected in the Upper Arm

Lead Sponsor:

FHI 360

Collaborating Sponsors:

Eastern Virginia Medical School

Conditions:

Contraception

Eligibility:

FEMALE

18-40 years

Phase:

NA

Brief Summary

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

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 Criteria

Inclusion

  • 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

  • \-

Key Trial Info

Start Date :

May 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2012

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT01143207

Start Date

May 1 2010

End Date

October 1 2012

Last Update

August 19 2013

Active Locations (1)

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1

Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School

Norfolk, Virginia, United States, 23507