PK of Depo SubQ Injected in the Upper Arm
- Registration Number
- NCT01143207
- Lead Sponsor
- FHI 360
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medroxyprogesterone acetate Medroxyprogesterone acetate Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
- Primary Outcome Measures
Name Time Method Tmax (Time to Cmax) 120 days following injection AUC 0-91 (Area Under Curve) first 91 days following injection Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) 120 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Center, Dept. of Obstetrics & Gynegology, Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States