Type 2 Diabetic Male With Hypogonadotrophic HypogonadismNCT00467987

Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism

A study testing androgel in people with Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism, run by University at Buffalo at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 31 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
What is being tested?: androgel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2007to 11 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 31 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Males with age 30-60 years inclusive.
PSA < 2.6 ng/ml or < 3.75 ng/ml with a negative prostate biopsy in the last 6 months.
IPSS ≤ 19. The lower age limit was decided on the fact that in our study on hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was 31 years old. The upper age limit has been restricted to 60 to avoid including subjects with significant age-related declines in testosterone concentrations.Subjects on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Subjects on insulin, metformin or sulfonylureas can participate in the study, provided that minimal changes are made to the doses during the study

Who cannot join

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c >10%;
h/o prostate carcinoma;
Hepatic disease (transaminase > 3 times normal) or cirrhosis;
Renal impairment (serum creatinine > 1.5);
HIV or Hepatitis C positive status;
Participation in any other concurrent clinical trial;

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Any other life-threatening, non-cardiac disease;
Use of over the counter health supplements which contain androgens;
Use of an investigational agent or therapeutic regimen within 30 days of study.
Use of testosterone in the past
Hematocrit > 50%.

Trial locations and contacts

1 site in 1 country.

United States1 site

Diabetes Endocrinology Research Center of WNY
Buffalo, New York, 14215

Other trials in United States

About this study

Official title: Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism.: a Prospective, Randomized and Controlled-Study

The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .

Read the detailed description

The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity . This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic men with low testosterone levels and comparing them to diabetic men with low testosterone who are not treated with testosterone. These groups will also be compared with diabetic men who have normal testosterone levels

Conditions: Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
Being tested: androgel, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

androgelDrug
androgel 1%
placeboDrug
Also called placebo gel
placebo

Study groups in NCT00467987
Study group	Role	What they receive
androgel	Experimental	androgel Receives: Drug: androgel
placebo	Placebo comparator	placebo gel Receives: Drug: placebo
no treatment	No intervention	eugonadal comparison arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Carotid Intima Media Thickness
carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).
Measured: 2 years

Secondary outcomes (1)

Endothelial Function
assessed by brachial artery Flow mediated dilatation (FMD in Centimeters)
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 200711 Oct 2018

First posted1 May 2007 (estimated)
Study start1 Jun 2007
Primary completion1 Mar 2018
Study completion11 Oct 2018

Why it stopped: Company no longer making same drug doses.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetic Male With Hypogonadotrophic HypogonadismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00467987
Sponsor's protocol ID: Androgel 1920
Status last verified: Feb 2024
First submitted: 27 Apr 2007
Last updated: 6 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism.: a Prospective, Randomized and Controlled-Study
ClinicalTrials.gov ID: NCT00467987
Acronym / sponsor ID: Androgel 1920
Conditions: Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
Study type: Interventional
Recruitment status: TerminatedReason stopped: Company no longer making same drug doses.
Enrolment: 47 participants (actual)
Lead sponsor: University at BuffaloUniversity, hospital or other
Collaborators: Solvay Pharmaceuticals
Study start: 1 Jun 2007 (actual)
Primary completion: 1 Mar 2018 (actual)
Study completion: 11 Oct 2018 (actual)
First posted: 1 May 2007 (estimated)
Results: Posted 6 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to examine the effects of testosterone deficiency in men with diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity .

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
androgel	Experimental	Drug: androgelandrogel
placebo	Placebo comparator	Drug: placeboplacebo gel
no treatment	No intervention	–eugonadal comparison arm

Who may qualify

Ages: 31 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Males with age 30-60 years inclusive.
PSA < 2.6 ng/ml or < 3.75 ng/ml with a negative prostate biopsy in the last 6 months.
IPSS ≤ 19. The lower age limit was decided on the fact that in our study on hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was 31 years old. The upper age limit has been restricted to 60 to avoid including subjects with significant age-related declines in testosterone concentrations.Subjects on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study. Subjects on insulin, metformin or sulfonylureas can participate in the study, provided that minimal changes are made to the doses during the study

Key exclusion criteria (11 listed)

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c >10%;
h/o prostate carcinoma;
Hepatic disease (transaminase > 3 times normal) or cirrhosis;
Renal impairment (serum creatinine > 1.5);
HIV or Hepatitis C positive status;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
androgelandrogel 1%	Drug	androgel
placeboAlso: placebo gelplacebo	Drug	placebo

Primary outcome

Carotid Intima Media Thickness
Time frame: 2 years
carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).

1 secondary outcome

Endothelial Function
Time frame: 2 years

Results and safety

Results posted to the registry on 6 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Androgel	13	10
Placebo	12	10
no Treatment	22	22

Primary outcome: Carotid Intima Media Thickness

Time frame: 2 years. Mean (Standard Deviation). Unit: centimeters (cm)

Measure	Androgel n = 10	Placebo n = 10	no Treatment n = 22
0 months	0.632 (0.115)	0.590 (0.127)	0.595 (0.190)
2 years	0.695 (0.214)	0.580 (0.133)	–

Population analysed: the no treatment group measurement was collected only at baseline and not followed beyond that point

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Androgel	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Placebo	0 of 10 (0%)	0 of 10 (0%)	0 of 10
no Treatment	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paresh Dandona principal investigator

Kaleida Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing androgel in people with Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism, run by University at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carotid Intima Media Thickness (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.