Halpern 2017.

Trial name or title	Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
Methods	Design: randomized, multicenter, open label Location: Portland OR (USA); Santo Domingo, Dominican Republic Time frame: September 2015 to August 2017 Sample size estimation and outcome of focus: no information
Participants	48 women Inclusion criteria: in good general health; aged 18 to 40 years; willing to provide consent and follow study requirements; negative urine pregnancy test on day of injection; does not become pregnant in next 24 months; regular menstrual cycle (27 to 35 days); confirmed ovulation in 2 consecutive samples during pre‐treatment phase; low risk of pregnancy; BMI 18 to 35; hemoglobin ≥ 10.5 g/L Exclusion criteria: medical contraindication to DMPA use; use of any investigational drug, prohibited drugs, OCs, LNG‐IUC or implant within 1 month prior to enrollment; use of DMPA in past 12 months; use of combined injectable contraceptive in past 6 months; recent pregnancy (within 3 months); current lactation; ongoing or anticipated use of prohibited drugs; known sensitivity to MPA; plan to move to another location in next 18 months
Interventions	1) 1 subcutaneous injection of 150 mg/mL DMPA in abdomen 2) 1 subcutaneous injection of 300 mg/mL DMPA in abdomen 3) 2 injections of 104 mg/0.65 mL DMPA in abdomen, given at 3‐month intervals
Outcomes	Primary: time to ovulation Secondary: weight at follow‐up; Cmax; aggregate of individual Cmax measurements and parameters; adverse events Follow‐up: 18 months
Starting date	September 2015; planned completion August 2017
Contact information	Vera Halpern, MD: FHI 360; vhalpern@fhi360.org; 919‐544‐7040 x11390
Notes

DMPA: depot medroxyprogesterone acetate
 LNG‐IUC: levonorgestrel‐releasing intrauterine contraception
 MPA: medroxyprogesterone acetate