Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
- Registration Number
- NCT02456584
- Lead Sponsor
- FHI 360
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DMPA 104 DMPA 104 two injections, given at three months intervals, of 104mg/0.65mL of DMPA in the abdomen DMPA 150 DMPA 150 single subcutaneous injection of 150mg/mL of DMPA in the abdomen DMPA 300 DMPA 300 single subcutaneous injection of 300mg/2mL of DMPA in the abdomen
- Primary Outcome Measures
Name Time Method Measure of time to ovulation up to 18 months
- Secondary Outcome Measures
Name Time Method Aggregate of individual Tmax measurements and parameters Up to 18 months Aggregate of individual C91 measurements and parameters 18 months after injection Terminal elimination half-life (t1/2) up to 18 months Up to ovulation or 18 months following injection, whichever comes first
Cmax up to 18 months Up to ovulation or 18 months following injection, whichever comes first
Pulse at follow up up to 18 months Aggregate of individual C182 measurements and parameters 18 months after injection Aggregate of individual C210 measurements and parameters 18 months after injection Type and frequency of adverse events up to 18 months Measure of delayed return to ovulation up to 18 months Weight at follow up up to 18 months MPA concentration at Day 91 (C91) 91 days after injection MPA concentration at Day 182 (C182) 182 days after injection Area under the curve (AUC 0-182) 182 days after injection Aggregate of individual Cmax measurements and parameters up to 18 months Blood pressure at follow up up to 18 months Serum concentrations of cortisol 7.5 months Number of participants with Injection site reactions up to 18 months Product acceptability up to 18 months Tmax up to 18 months Up to ovulation or 18 months following injection, whichever comes first
MPA concentration at Day 210 (C210) 210 days after injection
Trial Locations
- Locations (2)
Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)
🇩🇴Santo Domingo, Dominican Republic
Oregon Health & Science University
🇺🇸Portland, Oregon, United States