Contraception Clinical Trial
Official title:
Pharmacodynamics (Suppression of Ovulation) and Pharmacokinetics Following a Single Subcutaneous Administration of Depo Provera® CI 150 mg/mL, Depo Provera® CI 300 mg/2 mL, or During Two Cycles of Depo-subQ Provera 104®
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
;
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