drugset / Trial / NCT01763541

Study of the Effect of Testosterone and Estradiol on NP Responses to Acute and Chronic Salt Loading

NCT01763541

Phase 0 Withdrawn Massachusetts General Hospital
RandomizedParallel-groupDouble-blindBasic science

Summary

There is gender dimorphism in cardiovascular risk, with men at higher risk than women. However, the fundamental basis for the protective effect of female sex remains unclear. Recent data implicate the natriuretic peptide (NP) system as an important determinant of blood pressure. Also, NP levels are twice as high in women of reproductive age than in men, and gonadal steroids are important determinants of circulating NPs. These are the marked, but poorly understood differences in the NP status between men and women. The investigators hypothesize that gonadal steroids regulate NP release, specifically that testosterone inhibits and estrogen activates the NP axis, leading to differences in both resting NP levels and dynamic responses of the NP, RAAS, and kidneys to acute and chronic salt loading. Understanding the basis for gender differences in NP function should provide important insights regarding mechanisms underlying hypertension in men versus women.

Timeline

Start
2014-06
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Background Anastrozole Other / unclassified
Background Leuprolide Other / unclassified 3.75 mg
Background Leuprolide Other / unclassified 7.5 mg

Indications