This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.
This is a randomized, multi-center, parallel-group Phase I study with a primary objective to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle. Secondary study objectives are: * To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of 150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered 3 months apart * To evaluate the relationship between serum MPA concentration and suppression of ovulation * To evaluate and compare the safety, tolerability and acceptability of a SC injection of DMPA of different frequencies, doses and volumes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
42
Oregon Health & Science University
Portland, Oregon, United States
Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)
Santo Domingo, Dominican Republic
Measure of time to ovulation
Time frame: up to 18 months
Cmax
Up to ovulation or 18 months following injection, whichever comes first
Time frame: up to 18 months
Aggregate of individual Cmax measurements and parameters
Time frame: up to 18 months
Type and frequency of adverse events
Time frame: up to 18 months
Blood pressure at follow up
Time frame: up to 18 months
Pulse at follow up
Time frame: up to 18 months
Weight at follow up
Time frame: up to 18 months
Measure of delayed return to ovulation
Time frame: up to 18 months
Serum concentrations of cortisol
Time frame: 7.5 months
Number of participants with Injection site reactions
Time frame: up to 18 months
Product acceptability
Time frame: up to 18 months
Tmax
Up to ovulation or 18 months following injection, whichever comes first
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Time frame: up to 18 months
Aggregate of individual Tmax measurements and parameters
Time frame: Up to 18 months
MPA concentration at Day 91 (C91)
Time frame: 91 days after injection
Aggregate of individual C91 measurements and parameters
Time frame: 18 months after injection
MPA concentration at Day 182 (C182)
Time frame: 182 days after injection
Aggregate of individual C182 measurements and parameters
Time frame: 18 months after injection
MPA concentration at Day 210 (C210)
Time frame: 210 days after injection
Aggregate of individual C210 measurements and parameters
Time frame: 18 months after injection
Area under the curve (AUC 0-182)
Time frame: 182 days after injection
Terminal elimination half-life (t1/2)
Up to ovulation or 18 months following injection, whichever comes first
Time frame: up to 18 months