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

NCT ID: NCT01763541

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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Natriuretic Peptides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Testosterone

To determine the effect of testosterone on the NP responses to acute and chronic salt loading.

One testosterone patch (Androderm 5 mg) applied to each male subject each day for 14 days.

Intervention: Leuprolide acetate and anastrozole

Group Type OTHER

leuprolide acetate

Intervention Type DRUG

Given to both arms to induce hypogonadism

Anastrozole

Intervention Type DRUG

Given to men to prevent conversion of administered testosterone to estradiol.

Estradiol

To determine the effect of estradiol on the NP responses to acute and chronic salt loading.

Two estradiol patches (Vivelle Dot 0.1mg) will be applied to each female subject twice-a-week for 2 weeks.

Intervention: leuprolide acetate

Group Type OTHER

leuprolide acetate

Intervention Type DRUG

Given to both arms to induce hypogonadism

Interventions

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leuprolide acetate

Given to both arms to induce hypogonadism

Intervention Type DRUG

Anastrozole

Given to men to prevent conversion of administered testosterone to estradiol.

Intervention Type DRUG

Other Intervention Names

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Lupron Depot 3.75 mg and 7.5 mg Arimidex

Eligibility Criteria

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Inclusion Criteria

* 18-40 years old
* no history of hypertension
* normal BMI
* Male: normal testosterone and free testosterone levels
* Female: regular menses, negative pregnancy test, no sex steroid therapy \>/=3 mos

Exclusion Criteria

* on hypertensives, diuretics, or insulin
* with diabetes mellitus
* estimated creatinine clearance \<60 ml/min
* prior cardiovascular, liver or renal disease
* history of hormonally-responsive cancer
* elevated liver function test (LFTs)
* atrial fibrillation
* abnormal sodium or potassium levels
* taking medications that directly impact the endocrine system (exogenous hormones, steroids, etc.)
* taking medications that indirectly impact the endocrine system (SSRIs, opioids, finasteride, etc.)
* with untreated hyper- or hypothyroidism
* smoker
* psychiatric history
* Women: not willing to abstain from getting pregnant during the course of the study, with abnormal menstrual cycle, or who have osteoporosis
* Men: with polycythemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Klahr Miller, MD

Director, Neuroendocrine Research Program in Women's Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012P002337

Identifier Type: -

Identifier Source: org_study_id