Trial Outcomes & Findings for Testosterone Patch's Effects on the Cardiovascular System and Libido (NCT NCT01208038)

Results Overview

Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (AtCor Medical Ltd., Sydney, Australia; software version 8.0). The central (ascending aortic) pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function. The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can then be calculated by analysis of the central waveform. Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the central pulse pressure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

12 weeks from baseline

Results posted on

2020-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Testosterone Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Testosterone Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Testosterone Patch's Effects on the Cardiovascular System and Libido

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone n=21 Participants Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Age, Continuous	53.0 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United Kingdom	21 Participants n=5 Participants
Augmentation Index	24.21 percentage of Arterial stiffness STANDARD_DEVIATION 10.70 • n=5 Participants
Reactive Hyperaemia Index	1.79 Reactive hyperaemia index STANDARD_DEVIATION 0.36 • n=5 Participants
Brief Profile of Female Sexual Function (B-PFSF)	15.3 units on a scale STANDARD_DEVIATION 9.1 • n=5 Participants
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	0.78 units on a scale STANDARD_DEVIATION 0.40 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks from baseline

Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (AtCor Medical Ltd., Sydney, Australia; software version 8.0). The central (ascending aortic) pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function. The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can then be calculated by analysis of the central waveform. Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the central pulse pressure.

Outcome measures

Outcome measures
Measure	Testosterone n=21 Participants Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Arterial Compliance - Augmentation Index	1.067 percentage of Arterial stiffness Interval -3.85 to 1.72

PRIMARY outcome

Timeframe: 12 weeks from baseline

Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischemia, compared to the control arm. Official reference values do not exist however a lower RHI (\<2.0) is usually considered indicative of endothelial dysfunction.

Outcome measures

Outcome measures
Measure	Testosterone n=17 Participants Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Endothelial Function	0.06 units on a scale Interval -0.19 to 0.31

SECONDARY outcome

Timeframe: 12 weeks from baseline

Blood samples were taken for fasting glucose and insulin levels. From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.

Outcome measures

Outcome measures
Measure	Testosterone n=21 Participants Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Insulin Resistance - HOMA-IR	0.106 units on a scale Interval -0.2 to 0.41

SECONDARY outcome

Timeframe: 12 weeks from baseline

Libido was assessed at each visit using the Brief profile of female sexual function (BPFSF), a validated self-administered questionnaire for identifying Hypoactive Sexual Desire Disorder (HSDD). The BPFSF is based on 7 questions. Each question is scored on a 6-point scale from 'always' to 'never'. A total score is total score ranging from 0 to 35. Previous studies have identified a score of less than 20 as suggestive of HSDD.

Outcome measures

Outcome measures
Measure	Testosterone n=21 Participants Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Libido - B-PFSF Score	5.05 units on a scale Interval 2.63 to 7.46

Adverse Events

Testosterone

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Testosterone n=21 participants at risk Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks Intrinsa Transdermal testosterone patch: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Skin and subcutaneous tissue disorders Skin irritation	19.0% 4/21 • 12 weeks
Endocrine disorders Increased facial hair	9.5% 2/21 • 12 weeks
Skin and subcutaneous tissue disorders Acne	4.8% 1/21 • 12 weeks
Reproductive system and breast disorders per vagina spotting	4.8% 1/21 • 12 weeks
Eye disorders Blepharitis	4.8% 1/21 • 12 weeks

Additional Information

Dr Kate Maclaran

Chelsea and Westminster NHS Trust

Phone: 020 3315 3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place