Testosterone Patch's Effects on the Cardiovascular System and Libido
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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
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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.
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
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 |

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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 ]

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Ages Eligible for Study: | 45 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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).

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 1111 | nickpanay@msn.com | |
Contact: Kate A Maclaran, MBChB | 0208 383 1111 ext 33913 | k.maclaran@imperial.ac.uk |
United Kingdom | |
Chelsea and Westminster Hospital | Not yet recruiting |
London, United Kingdom, SW10 9NH | |
Contact: Nick Panay, MBBS nickpanay@msn.com | |
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 nickpanay@msn.com | |
Contact: Kate Maclaran, MBChB 0208 383 1111 ext 33193 k.maclaran@imperial.ac.uk | |
Principal Investigator: Nick Panay, MBBS | |
Royal Brompton Hospital | Not yet recruiting |
London, United Kingdom | |
Contact: Kate Maclaran, MBChB k.maclaran@imperial.ac.uk | |
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 |
Responsible Party: | Becky Ward, Imperial College London |
ClinicalTrials.gov Identifier: | NCT01208038 History of Changes |
Other Study ID Numbers: |
CRO1646 |
First Posted: | September 23, 2010 Key Record Dates |
Last Update Posted: | September 23, 2010 |
Last Verified: | September 2010 |
Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological Mental Disorders Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |