Testosterone Regulation of the Natriuretic Peptide System

NCT02269072 | Withdrawn DMC

• 1 other identifier: 2014P00
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration.

Conditions

Hypertension

Keywords

Natriuretic Peptide

Outcome Measures

Primary Outcomes (1)

• Atrial natriuretic peptide levels

  8 weeks

Secondary Outcomes (1)

• Urinary salt excretion

  8 weeks

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Testosterone cream applied daily

Drug: Testosterone; Drug: Nesiritide; Drug: Leuprolide; Drug: Anastrozole

Placebo

PLACEBO COMPARATOR

Identical placebo cream applied daily

Drug: Nesiritide; Drug: Leuprolide; Drug: Anastrozole; Drug: Placebo

Interventions

Testosterone DRUG

Testosterone cream applied daily for two weeks

Testosterone

Nesiritide DRUG

Administered IV once during the study

Placebo; Testosterone

Leuprolide DRUG

Administered twice during the study by injection

Placebo; Testosterone

Anastrozole DRUG

Daily pill for 8 weeks

Placebo; Testosterone

Placebo DRUG

Inert cream otherwise identical to testosterone cream applied daily for two weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and 25.
• Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25.

You may not qualify if:

• Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Hypertension

Interventions

Testosterone; Natriuretic Peptide, Brain; Leuprolide; Anastrozole

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Peptides; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Oligopeptides; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Karen K Miller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuroendocrine Research Program in Women's Health

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 19, 2017

Record last verified: 2017-10