Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the
minimum effective dose of progesterone microspheres suspension, which administered by weekly
intramuscular injection, will be able to induce transformation from a proliferative
endometrium to a secretory endometrium.
Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.
Sites: 1 Subjects: 48 postmenopausal women.