Trial Outcomes & Findings for Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism (NCT NCT00467987)

NCT ID: NCT00467987

Last Updated: 2024-02-06

Results Overview

carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2024-02-06

Participant Flow

Participant milestones

Measure	Androgel androgel androgel: androgel 1% once daily	Placebo placebo gel placebo: placebo gel once daily	no Treatment Eugonadal comparison arm- Baseline visit. No intervention performed
Overall Study STARTED	13	12	22
Overall Study COMPLETED	10	10	22
Overall Study NOT COMPLETED	3	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Androgel n=13 Participants androgel androgel: androgel 1%	Placebo n=12 Participants placebo gel placebo: placebo	no Treatment n=22 Participants eugonadal comparison arm	Total n=47 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 5.7 • n=13 Participants	63.8 years STANDARD_DEVIATION 10.2 • n=12 Participants	50.1 years STANDARD_DEVIATION 7.8 • n=22 Participants	59.3 years STANDARD_DEVIATION 6.6 • n=47 Participants
Sex: Female, Male Female	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=22 Participants	0 Participants n=47 Participants
Sex: Female, Male Male	13 Participants n=13 Participants	12 Participants n=12 Participants	22 Participants n=22 Participants	47 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body mass index (BMI)	38.7 Kg/m2 STANDARD_DEVIATION 7.6 • n=13 Participants	37.3 Kg/m2 STANDARD_DEVIATION 10.2 • n=12 Participants	34.9 Kg/m2 STANDARD_DEVIATION 6.4 • n=22 Participants	36.1 Kg/m2 STANDARD_DEVIATION 6.9 • n=47 Participants
total testosteron	218 ng/dl STANDARD_DEVIATION 102 • n=13 Participants	241 ng/dl STANDARD_DEVIATION 57 • n=12 Participants	465 ng/dl STANDARD_DEVIATION 152 • n=22 Participants	337 ng/dl STANDARD_DEVIATION 105 • n=47 Participants

PRIMARY outcome

Timeframe: 2 years

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

carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).

Outcome measures

Measure	Androgel n=10 Participants androgel androgel: androgel 1%	Placebo n=10 Participants placebo gel placebo: placebo	no Treatment n=22 Participants eugonadal comparison arm
Carotid Intima Media Thickness 0 months	0.632 centimeters (cm) Standard Deviation 0.115	0.590 centimeters (cm) Standard Deviation 0.127	0.595 centimeters (cm) Standard Deviation 0.190
Carotid Intima Media Thickness 2 years	0.695 centimeters (cm) Standard Deviation 0.214	0.580 centimeters (cm) Standard Deviation 0.133	—

SECONDARY outcome

Timeframe: 2 years

Population: the no treatment group was not followed beyond baseline so no 2 years data will be entered.

assessed by brachial artery Flow mediated dilatation (FMD in Centimeters)

Outcome measures

Measure	Androgel n=10 Participants androgel androgel: androgel 1%	Placebo n=10 Participants placebo gel placebo: placebo	no Treatment n=22 Participants eugonadal comparison arm
Endothelial Function 0 months	0.469 centimeters (cm) Standard Deviation 0.054	0.523 centimeters (cm) Standard Deviation 0.119	0.474 centimeters (cm) Standard Deviation 0.087
Endothelial Function 2 years	0.440 centimeters (cm) Standard Deviation 0.109	0.483 centimeters (cm) Standard Deviation 0.106	—

Adverse Events

Androgel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paresh Dandona

State University of NY at Buffalo

Phone: 17165351852

Email: dandona@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place