PK of Depo SubQ Injected in the Upper Arm

Contraception Clinical Trial

Official title:

Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143207
• Other study ID #: 10206
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: August 5, 2013
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: August 2013
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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:

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Medroxyprogesterone acetate
Injectable hormonal contraceptive

Locations

Country	Name	City	State
United States	Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))		120 days following injection	No
Primary	Tmax (Time to Cmax)		120 days following injection	No
Primary	AUC 0-91 (Area Under Curve)		first 91 days following injection	No
Primary	MPA Concentration at Day 91 (C91)		day 91 after first injection	No
Primary	MPA Concentration at Day 104 (C104)		day 104 after injection	No
Primary	MPA Concentration at Day 120 (C120)		day 120 after injection	No