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| Name | Class |
|---|---|
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| Chelsea and Westminster NHS Foundation Trust | OTHER |
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The purpose of this study is to examine the effect of the testosterone patch, in addition to hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.
A woman's ovaries produce the hormone testosterone during her reproductive life but testosterone levels decline with age or when the ovaries are removed. Testosterone has been associated with sexual desire in both men and women. Low testosterone is also believed to cause symptoms of low energy. Thus testosterone is increasingly used in hormone replacement regimens to restore libido and energy in postmenopausal women.
In the past testosterone has been administered orally or via subcutaneous implants. Recently testosterone patches have been licensed for treating low libido in postmenopausal women. The testosterone patches deliver a dose of testosterone equivalent to the levels produced by the ovary during a woman's early reproductive years.
Oral testosterone can lead to changes to insulin and cholesterol levels which increase the risk of heart disease. On the contrary, testosterone patches may reduce or avoid this risk. To date, trials have predominantly focused on safety data in terms of side effects and basic blood tests. Reviews of the safety of testosterone replacement have emphasised the need for improved safety data, especially in terms of cardiovascular risk.
The investigators hypothesis that transdermal testosterone, in addition to HRT, will have no adverse effects on blood vessel walls and insulin levels and that transdermal testosterone significantly improves sexuality and psychological well-being in postmenopausal women.
Trial design:
The investigators aim to recruit 20 postmenopausal women to wear the testosterone patch for 3 months in addition to their usual hormone replacement therapy.
There will be 3 study visits - a pre study visit, week 6 and week 12. At each visit the following procedures will be performed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Experimental | Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrinsa Transdermal testosterone patch | Drug | 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Compliance - Augmentation Index | 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. | 12 weeks from baseline |
| Endothelial Function | 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. | 12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance - HOMA-IR | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nick Panay, MBBS | Imperial College Healthcare NHS Trust | Principal Investigator |
| John C Stevenson, MBBS | Royal Brompton and Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom | |||
| Queen Charlotte's and Chelsea Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patient withdrew before baseline characteristics and starting study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Arterial Compliance - Augmentation Index | 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. | Posted | Mean | 95% Confidence Interval | percentage of Arterial stiffness | 12 weeks from baseline |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kate Maclaran | Chelsea and Westminster NHS Trust | 020 3315 3000 | kate.maclaran@nhs.net |
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C503596 | Intrinsa |
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| 12 weeks from baseline |
| Libido - B-PFSF Score | 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. | 12 weeks from baseline |
| London |
| W14 0HS |
| United Kingdom |
| Royal Brompton Hospital | London | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Augmentation Index | Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (software version 8.0). The central 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 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. | Mean | Standard Deviation | percentage of Arterial stiffness |
|
| Reactive Hyperaemia Index | Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischaemia, compared to the control arm. Official reference values do not exists however a lower RHI (<2.0) is usually considered indicative of endothelial dysfunction. | Mean | Standard Deviation | Reactive hyperaemia index |
|
| Brief Profile of Female Sexual Function (B-PFSF) | 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 calculated from a sum of all questions. Previous studies have identified a score of less than 20 as suggestive of HSDD. | Mean | Standard Deviation | units on a scale |
|
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Endothelial Function | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Insulin Resistance - HOMA-IR | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks from baseline |
|
|
|
| Secondary | Libido - B-PFSF Score | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks from baseline |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 7 |
| 21 |
| Increased facial hair | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| per vagina spotting | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
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