Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- FHI 360
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Arms & Interventions
Medroxyprogesterone acetate
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Intervention: Medroxyprogesterone acetate (Drug)
Outcomes
Primary Outcomes
Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
Time Frame: 120 days following injection
Tmax (Time to Cmax)
Time Frame: 120 days following injection
AUC 0-91 (Area Under Curve)
Time Frame: first 91 days following injection
MPA Concentration at Day 91 (C91)
Time Frame: day 91 after first injection
MPA Concentration at Day 104 (C104)
Time Frame: day 104 after injection
MPA Concentration at Day 120 (C120)
Time Frame: day 120 after injection
Secondary Outcomes
No secondary outcomes reported