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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
Age
18 - 40 years
Sex
FEMALE
Healthy Volunteers
Yes
Oregon Health & Science University
Portland, Oregon, United States
Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)
Santo Domingo, Dominican Republic
Start Date
September 1, 2015
Primary Completion Date
August 30, 2018
Completion Date
August 30, 2018
Last Updated
October 18, 2018
42
ACTUAL participants
DMPA 150
DRUG
DMPA 300
DRUG
DMPA 104
DRUG
Lead Sponsor
FHI 360
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06672016