Conditions: Contraception
Keywords: AE adverse event DCF data collection forms DMC Data Monitoring Committee FDA U.S.) Food and Drug Administration GCP Good Clinical Practice guidelines ICH International Conference of Harmonisation IND Investigational New Drug Application IRB Institutional Review Board IU International units mg milligram(s) SAE serious adverse event µg microgram ULN upper limit of the normal range
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: yes

Brief summary:
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception

Detailed description:
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm

Arms:
arm 1: Single injection of Medroxyprogesterone acetate (hormonal contraceptive)

Interventions: intervention 1: Medroxyprogesterone acetate
Intervention descriptions: intervention 1: Injectable hormonal contraceptive

Protocol document: