Testosterone Patch's Effects on the Cardiovascular System and Libido
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01208038|
Recruitment Status : Unknown
Verified September 2010 by Imperial College Healthcare NHS Trust.
Recruitment status was: Not yet recruiting
First Posted : September 23, 2010
Last Update Posted : September 23, 2010
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 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.
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.
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
|Condition or disease||Intervention/treatment||Phase|
|Hypoactive Sexual Desire Disorder||Drug: Intrinsa Transdermal testosterone patch||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||October 2011|
Drug: Intrinsa Transdermal testosterone patch
- Arterial compliance [ Time Frame: 12 weeks ]
- Endothelial function [ Time Frame: 12 weeks ]
- Insulin resistance [ Time Frame: 6 and 12 weeks ]
- Libido [ Time Frame: 6 and 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208038
|Contact: Nick Panay, MBBS||0208 383 firstname.lastname@example.org|
|Contact: Kate A Maclaran, MBChB||0208 383 1111 ext email@example.com|
|Chelsea and Westminster Hospital||Not yet recruiting|
|London, United Kingdom, SW10 9NH|
|Contact: Nick Panay, MBBS firstname.lastname@example.org|
|Principal Investigator: Nick Panay, MBBS|
|Queen Charlotte's and Chelsea Hospital||Not yet recruiting|
|London, United Kingdom, W14 0HS|
|Contact: Nick Panay, MBBS 0208 383 1111 email@example.com|
|Contact: Kate Maclaran, MBChB 0208 383 1111 ext 33193 firstname.lastname@example.org|
|Principal Investigator: Nick Panay, MBBS|
|Royal Brompton Hospital||Not yet recruiting|
|London, United Kingdom|
|Contact: Kate Maclaran, MBChB email@example.com|
|Principal Investigator: John Stevenson, MBBS|
|Sub-Investigator: Peter Collins, MBBChir|
|Principal Investigator:||Nick Panay, MBBS||Imperial College Healthcare NHS Trust|
|Principal Investigator:||John C Stevenson, MBBS||Royal Brompton and Harefield NHS Foundation Trust|