Testosterone Patch's Effects on the Cardiovascular System and Libido

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 Design

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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

Arms and Interventions

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Intervention Details:

Drug: Intrinsa Transdermal testosterone patch
300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Other Name: Intrinsa

Outcome Measures

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Primary Outcome Measures :

1. Arterial compliance [ Time Frame: 12 weeks ]
2. Endothelial function [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Insulin resistance [ Time Frame: 6 and 12 weeks ]
2. Libido [ Time Frame: 6 and 12 weeks ]

Eligibility Criteria

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

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).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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

Sponsors and Collaborators

Imperial College Healthcare NHS Trust

Royal Brompton & Harefield NHS Foundation Trust

Chelsea and Westminster NHS Foundation Trust

Investigators

Principal Investigator:	Nick Panay, MBBS	Imperial College Healthcare NHS Trust
Principal Investigator:	John C Stevenson, MBBS	Royal Brompton and Harefield NHS Foundation Trust

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Becky Ward, Imperial College London
ClinicalTrials.gov Identifier:	NCT01208038 History of Changes
Other Study ID Numbers:	CRO1646
First Posted:	September 23, 2010
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