The purpose of the study is to compare the pharmacokinetics and relative bioavailability of medroxyprogesterone in healthy female participants following subcutaneous injection of Sayana Press into the upper arm versus anterior thigh and abdomen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
67
Sayana Press is a drug-device combination and is considered a medical product in the EU.
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
Serum Trough Concentration (Ctrough) of Medroxyprogesterone
Time frame: Day 92 post dose
Area under the curve from time zero to end of dosing interval (AUCtau)
Time frame: pre-dose, up to 92 days post dose
Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone
Time frame: pre-dose, up to 92 days post dose
Serum Progesterone Level
Time frame: pre-dose, up to 99 days post dose
Serum Estradiol Level
Time frame: pre-dose, up tp 99 days post dose
Serum Luteinizing Hormone (LH) Level
Time frame: pre-dose, up to 99 days post dose
Serum Follicle-Stimulating Hormone (FSH) Level
Time frame: pre-dose, up to 99 days post dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Informed consent document to 150 days post dose or until study completion, whichever is longer.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: baseline, up to 150 days post dose or until study completion, whichever is longer
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Screening, Day 1, up to 150 days post dose or until study completion, whichever is longer
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