Testosterone Patch's Effects on the Cardiovascular System and Libido

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Imperial College Healthcare NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
Chelsea and Westminster NHS Foundation Trust
Information provided by:
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01208038
First received: September 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 22, 2010
September 22, 2010
October 2010
October 2011   (final data collection date for primary outcome measure)
  • Arterial compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Insulin resistance [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: Yes ]
  • Libido [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Testosterone Patch's Effects on the Cardiovascular System and Libido
Pilot Study: Evaluating the Effect of 300 Micrograms Testosterone Patches in Addition to Hormone Replacement Therapy on Arterial Compliance, Insulin Resistance 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 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
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hypoactive Sexual Desire Disorder
Drug: Intrinsa Transdermal testosterone patch
300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Other Name: Intrinsa
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
October 2011
October 2011   (final data collection date for primary outcome measure)

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).
Female
45 Years to 70 Years
No
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
 
NCT01208038
CRO1646
No
Becky Ward, Imperial College London
Imperial College Healthcare NHS Trust
  • Royal Brompton & Harefield NHS Foundation Trust
  • Chelsea and Westminster NHS Foundation Trust
Principal Investigator: Nick Panay, MBBS Imperial College Healthcare NHS Trust
Principal Investigator: John C Stevenson, MBBS Royal Brompton and Harefield NHS Foundation Trust
Imperial College Healthcare NHS Trust
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP