NCT00425568

Brief Summary

Low testosterone may be responsible for "soft" erections in men. The purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the "hardness" of a man's erection.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
Last Updated

August 8, 2018

Status Verified

December 1, 2007

First QC Date

January 20, 2007

Last Update Submit

August 7, 2018

Conditions

Hypogonadism

Keywords

hypogonadismlow testosterone levelgonadal deficiency

Interventions

AndroGel (Transdermal Testosterone Gel)DRUG

Eligibility Criteria

Age21 Years - 59 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Testosterone \<350 ng/dL,
  • years of age,
  • BMI \<30

You may not qualify if:

  • Those with carcinoma of the breast or known or suspected carcinoma of the prostate or with known hypersensitivity to any of the ingredients in AndroGel.
  • Men will be excluded if they have unstable angina, hypertension, diabetes, heart failure, or coronary artery disease.
  • Men will agree to discontinue use of current testosterone replacement, as well as Viagra or any other PDE5 inhibitors for 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steven Lamm, M.D.

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Steven Lamm, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV

Study Record Dates

First Submitted

January 20, 2007

First Posted

January 23, 2007

Study Start

December 1, 2005

Last Updated

August 8, 2018

Record last verified: 2007-12

Locations

US(1)