Sites: 1~Phase: 1~Main objective:~To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration.~Secondary objectives:~To determine bioavailability of each of the formulations studied, after multiple-dose-administration. Describe tolerability of each of the formulations studied, after multiple-dose administration.~Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study~Investigational Products:~Estradiol and progesterone microspheres aqueous suspension (1 mg/20 mg)~Estradiol and progesterone microspheres aqueous suspension (0.5 mg/15 mg)~Study subjects: 30 postmenopausal women 45 - 65 years old~Brief description: After written informed consent, 30 eligible women will be randomized to study treatments (one IM injection each 28 days, for a total of 4 doses). Blood samples will be obtained for pharmacokinetic study.
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