drugset / Trial / NCT01293747

Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

NCT01293747

Phase 1 Completed 30 enrolled Productos Científicos S. A. de C. V.
RandomizedParallel-groupOpen-labelTreatment

Summary

Phase I pharmacokinetic study Main objective: To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study Sites: 1 Subjects: 30 postmenopausal women

Timeline

Start
2011-02
Primary completion
2011-08
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 0.5 mg Intramuscular
Subject Estradiol Other / unclassified 1 mg Intramuscular
Subject Progesterone Other / unclassified 15 mg Intramuscular
Subject Progesterone Other / unclassified 20 mg Intramuscular

Indications

No indication recorded.