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
  Purpose

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 Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: Intrinsa Transdermal testosterone patch
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Imperial College Healthcare NHS Trust:

Primary Outcome Measures:
  • Arterial compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Endothelial function [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Intrinsa Transdermal testosterone patch
    300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
    Other Name: Intrinsa
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208038

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
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         
Chelsea and Westminster Hospital Not yet recruiting
London, United Kingdom, SW10 9NH
Contact: Nick Panay, MBBS       nickpanay@msn.com   
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

No publications provided

Responsible Party: Becky Ward, Imperial College London
ClinicalTrials.gov Identifier: NCT01208038     History of Changes
Other Study ID Numbers: CRO1646
Study First Received: September 22, 2010
Last Updated: September 22, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014