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drugset / Trial / NCT01176175

Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

NCT01176175 ↗

Phase 1 Completed 48 enrolled Productos Científicos S. A. de C. V.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2010-12
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Progesterone Other / unclassified 50 mg Intramuscular
Subject Progesterone Other / unclassified 100 mg Intramuscular
Subject Progesterone Other / unclassified 200 mg Intramuscular
Subject Progesterone Other / unclassified 300 mg Intramuscular

Indications

infertility disorder