NCT02715713

Brief Summary

The primary goal of this pilot study is to investigate the association between testosterone deficiency and the presence of abnormalities in the function of the autonomic nervous system. If such association exists, then we will investigate the effect of testosterone replacement therapy on correcting these abnormalities.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

March 17, 2016

Last Update Submit

October 14, 2016

Conditions

Autonomic NeuropathyMale Hypogonadism

Keywords

Autonomic neuropathy, Testosterone Deficiency

Outcome Measures

Primary Outcomes (1)

  • Number of patients with testosterone deficiency who will have abnormal autonomic function test (abnormal heart rate response to deep breathing, abnormal Valsalva ratio, and abnormal tilt table i.e. orthostatic hypotension).

    24 months

Secondary Outcomes (1)

  • Number of patients with testosterone deficiency and abnormal autonomic function test who will have such abnormalities corrected if they receive testosterone replacement therapy as part of standard of care.

    24 months

Study Arms (2)

testosterone deficiency group

Men between the ages of 40 to 80-years-old with testosterone deficiency

prostate cancer group

Men between the ages of 40 to 80-years-old with prostate cancer that will result in testosterone deficiency due to surgical or pharmacological castration.

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two groups will be recruited with 20 men in each group: Group 1 will include 20 men between the ages of 40 to 80-years-old with symptoms and biochemical parameters of low testosterone. Group 2 will include 20 men between the ages of 40 to 80-years-old with prostate cancer and normal serum testosterone that will be treated with surgical or pharmacological castration, as following standard of care at Urology Division, resulting in testosterone deficiency.

You may qualify if:

  • Patients with testosterone deficiency (total testosterone\< 277 ng/dL \[9.6 nmol/L\]) measured between 7-10 am, and with one or more symptoms and signs suggestive of androgen deficiency as mainly determined by history.
  • Reduced sexual desire (libido)
  • Decreased spontaneous erections
  • Breast discomfort, gynecomastia
  • Loss of body (axillary and pubic) hair - reduced shaving
  • Very small (\<5ml) or shrinking testes
  • Height loss
  • Low trauma fracture
  • Low bone mineral density
  • Hot flushes
  • Sweats
  • Decreased energy
  • Decreased motivation
  • Decreased initiative
  • Decreased self confidence
  • +10 more criteria

You may not qualify if:

  • \. Patients with history or current diagnosis of:
  • Atrial fibrillation.
  • Cardiac arrythmia
  • Pacemaker placement.
  • Myocardial infarction \< 3 months
  • Uncontrolled diabetes mellitus with hemoglobin A1c \> 8.5% in the last 6 months.
  • Diabetes mellitus with autonomic neuropathy
  • Breast cancer
  • Heart failure with left ventricular ejection fraction below 35%.
  • Severe sleep apnea.
  • Recent eye surgery (\< 3 months)
  • Recent ischemic stroke (\< 3 months)
  • History of retinal detachment.
  • History of brain aneurysm.
  • Severe chronic obstructive pulmonary disease (COPD) on oxygen therapy.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Eunuchism

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System Diseases

Study Officials

  • Ahmed M Eldokla, MD

    Texas Tech Universty Health Science Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 22, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

US(1)