PK of Depo SubQ Injected in the Upper Arm

FHI 36026 enrolled

Overview

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

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

Allocation

Masking

NONE

Enrollment

Conditions

Contraception

Interventions

Medroxyprogesterone acetateDRUG

Injectable hormonal contraceptive

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (1)

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

Norfolk, Virginia, United States

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

Data from ClinicalTrials.gov

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