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Testosterone Patch's Effects on the Cardiovascular System and Libido

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Intrinsa Transdermal testosterone patch
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoactive Sexual Desire Disorder focused on measuring Hypoactive sexual desire disorder

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • healthy postmenopausal women
  • 45 to 70 years of age
  • on HRT and willing to continue the same HRT regimen for the next 6 months
  • are in a stable relationship which was started at least 6 months ago
  • continue on any concomitant medications without any change during the study
  • give informed consent.

Exclusion Criteria:

  • have dyspareunia
  • have received testosterone implants within the last 12 months or other androgen therapy within the last 6 months
  • have received any medications which may interfere with the study (SSRI, anti-androgens, PDE5 inhibitors, DHEA, SERMS)
  • have a significant psychiatric disorder
  • have a history of breast cancer
  • have diabetes, thromboembolic disorders, cardiovascular disease, any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia
  • are on tibolone (due to its androgenic effect).

Sites / Locations

  • Chelsea and Westminster Hospital
  • Queen Charlotte's and Chelsea Hospital
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Testosterone

Arm Description

Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 22, 2010
Last Updated
December 13, 2019
Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01208038
Brief Title
Testosterone Patch's Effects on the Cardiovascular System and Libido
Official Title
Pilot Study: Evaluating the Effect of 300 Micrograms Testosterone Patches in Addition to Hormone Replacement Therapy on Arterial Compliance, Insulin Resistance and Sexual Desire.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust
Collaborators
Royal Brompton & Harefield NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: Medical history and physical examination Blood sample - for hormone levels, lipids and insulin levels Blood vessel stiffness measurements This will be performed using a small ultrasound device at the wrist with blood pressure measured every 5 minutes. Endothelial function (function of your arterial wall) is measured using a blood pressure cuff on each arm and finger probes on one finger of each hand. The blood pressure cuff is inflated for 5 minutes and is then deflated quickly. The finger probes will record the readings throughout this study. Sexual satisfaction questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
Hypoactive sexual desire disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone
Arm Type
Experimental
Arm Description
Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Intrinsa Transdermal testosterone patch
Other Intervention Name(s)
Intrinsa
Intervention Description
300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Primary Outcome Measure Information:
Title
Arterial Compliance - Augmentation Index
Description
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.
Time Frame
12 weeks from baseline
Title
Endothelial Function
Description
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.
Time Frame
12 weeks from baseline
Secondary Outcome Measure Information:
Title
Insulin Resistance - HOMA-IR
Description
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.
Time Frame
12 weeks from baseline
Title
Libido - B-PFSF Score
Description
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.
Time Frame
12 weeks from baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: healthy postmenopausal women 45 to 70 years of age on HRT and willing to continue the same HRT regimen for the next 6 months are in a stable relationship which was started at least 6 months ago continue on any concomitant medications without any change during the study give informed consent. Exclusion Criteria: have dyspareunia have received testosterone implants within the last 12 months or other androgen therapy within the last 6 months have received any medications which may interfere with the study (SSRI, anti-androgens, PDE5 inhibitors, DHEA, SERMS) have a significant psychiatric disorder have a history of breast cancer have diabetes, thromboembolic disorders, cardiovascular disease, any condition affecting carbohydrate metabolism, uncontrolled hypertension and uncontrolled hyperlipidaemia are on tibolone (due to its androgenic effect).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Panay, MBBS
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John C Stevenson, MBBS
Organizational Affiliation
Royal Brompton and Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Queen Charlotte's and Chelsea Hospital
City
London
ZIP/Postal Code
W14 0HS
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Testosterone Patch's Effects on the Cardiovascular System and Libido

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