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Completed

NCT Number: NCT01143207

PK of Depo SubQ Injected in the Upper Arm

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

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Norfolk, Virginia, 23507, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Medroxyprogesterone Acetate

Drug

Injectable hormonal contraceptive

Other names: Depo-SubQ Provera 104

Primary outcomes

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

    Time frame: 120 days following injection

  2. Tmax (Time to Cmax)

    Time frame: 120 days following injection

  3. AUC 0-91 (Area Under Curve)

    Time frame: first 91 days following injection

  4. MPA Concentration at Day 91 (C91)

    Time frame: day 91 after first injection

  5. MPA Concentration at Day 104 (C104)

    Time frame: day 104 after injection

  6. MPA Concentration at Day 120 (C120)

    Time frame: day 120 after injection

Sponsors and collaborators

Lead sponsor

FHI 360

Other

Collaborators

  • Eastern Virginia Medical School

Registry information

Official study title

Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 14, 2010
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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