Trial Outcomes & Findings for Testosterone for Peripheral Vascular Disease (NCT NCT00504712)

Results Overview

The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

Baseline, 12 weeks, and 26 weeks

Results posted on

2022-06-08

Participant Flow

started 02/02/2006

Participant milestones

Participant milestones
Measure	Active Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Placebo Saline saline: Saline injection every two weeks
Overall Study STARTED	11	13
Overall Study COMPLETED	11	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=11 Participants Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Placebo n=13 Participants Saline saline: Saline injection every two weeks	Total n=24 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 11.9 • n=11 Participants	61.7 years STANDARD_DEVIATION 11.8 • n=13 Participants	59.15 years STANDARD_DEVIATION 11.85 • n=24 Participants
Sex: Female, Male Female	0 Participants n=11 Participants	0 Participants n=13 Participants	0 Participants n=24 Participants
Sex: Female, Male Male	11 Participants n=11 Participants	13 Participants n=13 Participants	24 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline, 12 weeks, and 26 weeks

The primary outcome was the effect of 12 weeks testosterone replacement on arterial stiffness measured by ultrasound derived stiffness parameter β of the femoral artery. A reduction in ultrasound derived stiffness parameter β is clinically beneficial to patients and the study was looking for a reduction in this value. Stiffness index β was calculated from the diastolic carotid artery diameter (Dd), systolic carotid artery diameter (Ds), diastolic blood pressure (BPd) and systolic blood pressure (BPs) using the formula; Stiffness index β = (ln(Ps/Pd)) x Dd/(Ds-Dd). A full theoretical range of possible index scores does not exist.

Outcome measures

Outcome measures
Measure	Active n=11 Participants Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Placebo n=13 Participants Saline saline: Saline injection every two weeks
Change in Arterial Stiffness Baseline	15.02 index β Standard Deviation 5.74	15.08 index β Standard Deviation 6.59
Change in Arterial Stiffness 12 weeks	14.08 index β Standard Deviation 5.36	16.12 index β Standard Deviation 7.42
Change in Arterial Stiffness 26 weeks	14.01 index β Standard Deviation 4.53	12.58 index β Standard Deviation 5.55

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 26 weeks

Progression of Carotid intima-media thickness measured in mm

Outcome measures

Outcome measures
Measure	Active n=11 Participants Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Placebo n=13 Participants Saline saline: Saline injection every two weeks
Change in IMT Baseline	0.856 mm Standard Deviation 0.132	0.885 mm Standard Deviation 0.130
Change in IMT 12 weeks	0.843 mm Standard Deviation 0.137	0.887 mm Standard Deviation 0.120
Change in IMT 26 weeks	0.841 mm Standard Deviation 0.135	0.872 mm Standard Deviation 0.124

Adverse Events

Active

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=11 participants at risk Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Placebo n=13 participants at risk Saline saline: Saline injection every two weeks
Cardiac disorders Serious	9.1% 1/11 • Number of events 1 Specific Adverse Event terms were not used for this study.	0.00% 0/13 Specific Adverse Event terms were not used for this study.
General disorders Serious	0.00% 0/11 Specific Adverse Event terms were not used for this study.	7.7% 1/13 • Number of events 1 Specific Adverse Event terms were not used for this study.
Renal and urinary disorders Adverse Event	0.00% 0/11 Specific Adverse Event terms were not used for this study.	7.7% 1/13 • Number of events 1 Specific Adverse Event terms were not used for this study.

Other adverse events

Other adverse events
Measure	Active n=11 participants at risk Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks	Placebo n=13 participants at risk Saline saline: Saline injection every two weeks
General disorders Adverse Event	9.1% 1/11 • Number of events 1 Specific Adverse Event terms were not used for this study.	0.00% 0/13 Specific Adverse Event terms were not used for this study.
Respiratory, thoracic and mediastinal disorders Adverse	9.1% 1/11 • Number of events 1 Specific Adverse Event terms were not used for this study.	0.00% 0/13 Specific Adverse Event terms were not used for this study.
Skin and subcutaneous tissue disorders Adverse	9.1% 1/11 • Number of events 1 Specific Adverse Event terms were not used for this study.	0.00% 0/13 Specific Adverse Event terms were not used for this study.
General disorders Adverse	0.00% 0/11 Specific Adverse Event terms were not used for this study.	7.7% 1/13 • Number of events 1 Specific Adverse Event terms were not used for this study.
Infections and infestations adverse	0.00% 0/11 Specific Adverse Event terms were not used for this study.	7.7% 1/13 • Number of events 1 Specific Adverse Event terms were not used for this study.

Additional Information

Professor TH Jones

Barnsley Hospital NHS Foundation Trust

Phone: 01226 431684

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place