NCT02456584

Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

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®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	DMPA 150	injectable contraceptive
DRUG	DMPA 300	injectable contraceptive
DRUG	DMPA 104	injectable contraceptive

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-08-30
• Completion: 2018-08-30
• First posted: 2015-05-28
• Last updated: 2018-10-18

Locations

2 sites across 2 countries: United States, Dominican Republic

Regulatory

• FDA-regulated drug study