An Early Phase 1 interventional study of leuprolide acetate and Anastrozole in Hypertension, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Basic science
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.
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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
Drug: leuprolide acetate · Drug: Anastrozole
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
Drug: leuprolide acetate
Given to both arms to induce hypogonadism
Also known as: Lupron Depot 3.75 mg and 7.5 mg
Given to men to prevent conversion of administered testosterone to estradiol.
Also known as: Arimidex
NP levels in men with testosterone patch and low-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of testosterone administration with low-salt diet
NP levels in men with testosterone patch and high-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of testosterone administration with high-salt diet
NP levels in women with estradiol patch and low-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of estradiol administration with low-salt diet
NP levels in women with estradiol patch and high-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of estradiol administration with high-salt diet
NP levels in men with placebo patch and low-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of placebo administration with low-salt diet
NP levels in men with placebo patch and high-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of placebo administration with high-salt diet
NP levels in women with placebo patch and low-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of placebo administration with low-salt diet
NP levels in women with placebo patch and high-salt diet
B-type natriuretic peptide (BNP), Atrial natriuretic peptide (ANP), amino-terminal brain natiuretic peptide (N-BNP), amino-terminal atrial natiuretic peptide (N-ANP), cyclic guanosine monophosphate (cGMP)
Time frame: At day 7 of week of placebo administration with high-salt diet
Plasma Renin Activity (PRA) levels in women on estradiol on low-salt diet
Plasma Renin Activity (PRA)
Time frame: At day 7 of week of estradiol administration on low-salt diet
Aldosterone levels in men with testosterone on low-salt diet
Aldosterone
Time frame: At day 7 of week of testosterone administration on low-salt diet
Plasma Renin Activity (PRA) levels in women on estradiol on high-salt diet
Plasma Renin Activity (PRA)
Time frame: At days 6 and 7 of week of estradiol administration on high-salt diet
Plasma Renin Activity (PRA) levels in women on placebo on low-salt diet
Plasma Renin Activity (PRA)
Time frame: At day 7 of week of placebo administration on low-salt diet
Plasma Renin Activity (PRA) levels in women on placebo on high-salt diet
Plasma Renin Activity (PRA)
Time frame: At days 6 and 7 of week of placebo administration on high-salt diet
Plasma Renin Activity (PRA) levels in men on testosterone on low-salt diet
Time frame: At day 7 of week of testosterone administration on low-salt diet
Plasma Renin Activity (PRA) levels in men on testosterone on high-salt diet
Time frame: At days 6 and 7 of week of testosterone administration on high-salt diet
Plasma Renin Activity (PRA) levels in men on placebo on low-salt diet
Time frame: At day 7 of week of placebo administration on low-salt diet
Plasma Renin Activity (PRA) levels in men on placebo on high-salt diet
Time frame: At days 6 and 7 of week of placebo administration on high-salt diet
Aldosterone levels in men on testosterone on high-salt diet
Time frame: At days 6 and 7 of week of testosterone administration on high-salt diet
Aldosterone levels in men on placebo on high-salt diet
Time frame: At days 6 and 7 of week of placebo administration on high-salt diet
Aldosterone levels in men on placebo on low-salt diet
Time frame: At day 7 of week of placebo administration on low-salt diet
Aldosterone levels in women on estradiol on high-salt diet
Time frame: At days 6 and 7 of week of estradiol administration on high-salt diet
Aldosterone levels in women on estradiol on low-salt diet
Time frame: At day 7 of week of estradiol administration on low-salt diet
Aldosterone levels in women on placebo on high-salt diet
Time frame: At days 6 and 7 of week of placebo administration on high-salt diet
Aldosterone levels in women on placebo on low-salt diet
Time frame: At day 7 of week of placebo administration on low-salt diet
Urinary sodium concentration in women on estradiol on high-salt diet
Time frame: 0, 60, and 120 minute of saline infusion on morning of day 7 of estradiol administration on high-salt diet
Urinary sodium concentration in women on placebo on high-salt diet
Time frame: 0, 60, and 120 minute of saline infusion on morning of day 7 of placebo administration on high-salt diet
Urinary sodium concentration in men on testosterone on high-salt diet
Time frame: 0, 60, and 120 minute of saline infusion on morning of day 7 of testosterone administration on high-salt diet
Urinary sodium concentration in men on placebo on high-salt diet
Time frame: 0, 60, and 120 minute of saline infusion on morning of day 7 of placebo administration on high-salt diet
This study is withdrawn, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital