PK of Depo SubQ Injected in the Upper Arm

Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate 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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Medroxyprogesterone acetate

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medroxyprogesterone acetate; Single injection of Medroxyprogesterone acetate (hormonal contraceptive)	Drug: Medroxyprogesterone acetate; Injectable hormonal contraceptive; Other Names: Depo-SubQ Provera 104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))	120 days following injection
Tmax (Time to Cmax)	120 days following injection
AUC 0-91 (Area Under Curve)	first 91 days following injection
MPA Concentration at Day 91 (C91)	day 91 after first injection
MPA Concentration at Day 104 (C104)	day 104 after injection
MPA Concentration at Day 120 (C120)	day 120 after injection

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Estimate): August 19, 2013
• Last Update Submitted That Met QC Criteria: August 5, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: AE adverse event; DCF data collection forms; DMC Data Monitoring Committee; GCP Good Clinical Practice guidelines; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; IU International units; mg milligram(s); SAE serious adverse event; µg microgram; ULN upper limit of the normal range; FDA U.S.) Food and Drug Administration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: 10206