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®
Overview
- Phase
- Phase 1
- Intervention
- DMPA 150
- Conditions
- Contraception
- Sponsor
- FHI 360
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Measure of time to ovulation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
DMPA 150
single subcutaneous injection of 150mg/mL of DMPA in the abdomen
Intervention: DMPA 150
DMPA 300
single subcutaneous injection of 300mg/2mL of DMPA in the abdomen
Intervention: DMPA 300
DMPA 104
two injections, given at three months intervals, of 104mg/0.65mL of DMPA in the abdomen
Intervention: DMPA 104
Outcomes
Primary Outcomes
Measure of time to ovulation
Time Frame: up to 18 months
Secondary Outcomes
- Product acceptability(up to 18 months)
- Terminal elimination half-life (t1/2)(up to 18 months)
- Cmax(up to 18 months)
- 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)
- Aggregate of individual Tmax measurements and parameters(Up to 18 months)
- Aggregate of individual C91 measurements and parameters(18 months after injection)
- 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)
- Number of participants with Injection site reactions(up to 18 months)
- Serum concentrations of cortisol(7.5 months)
- Tmax(up to 18 months)
- MPA concentration at Day 210 (C210)(210 days after injection)