- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01208038
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- Royal Brompton Hospital
-
London, United Kingdom, SW10 9NH
- Chelsea and Westminster Hospital
-
London, United Kingdom, W14 0HS
- Queen Charlotte's and Chelsea Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Testosterone
Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks
|
300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial Compliance - Augmentation Index
Time Frame: 12 weeks from baseline
|
Peripheral pressure waveforms were captured using radial artery application tonometry via the SphygmoCor apparatus (AtCor Medical Ltd., Sydney, Australia; software version 8.0).
The central (ascending aortic) pressure waveform was then derived from an averaged peripheral waveform using a validated, transfer function.
The augmentation index (AIx), which gives a composite measure of wave reflection and systemic arterial stiffness can then be calculated by analysis of the central waveform.
Aix was defined as the difference between the first and second systolic peaks of the central pressure waveform, expressed as a percentage of the central pulse pressure.
|
12 weeks from baseline
|
Endothelial Function
Time Frame: 12 weeks from baseline
|
Reactive Hyperaemia Index (RHI) was calculated automatically by the EndoPAT 2000 computer algorithm from the ratio of pulse wave amplitude before and after ischemia, compared to the control arm.
Official reference values do not exist however a lower RHI (<2.0) is usually considered indicative of endothelial dysfunction.
|
12 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Resistance - HOMA-IR
Time Frame: 12 weeks from baseline
|
Blood samples were taken for fasting glucose and insulin levels.
From these results, insulin resistance was then estimated using the updated homeostasis model assessment method for insulin resistance (HOMA-IR) computer algorithm.
A higher HOMA-IR indicates a higher degree of insulin resistance.
Typically a cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.
|
12 weeks from baseline
|
Libido - B-PFSF Score
Time Frame: 12 weeks from baseline
|
Libido was assessed at each visit using the Brief profile of female sexual function (BPFSF), a validated self-administered questionnaire for identifying Hypoactive Sexual Desire Disorder (HSDD).
The BPFSF is based on 7 questions.
Each question is scored on a 6-point scale from 'always' to 'never'.
A total score is total score ranging from 0 to 35.
Previous studies have identified a score of less than 20 as suggestive of HSDD.
|
12 weeks from baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nick Panay, MBBS, Imperial College Healthcare NHS Trust
- Principal Investigator: John C Stevenson, MBBS, Royal Brompton and Harefield NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Hypokinesia
- Sexual Dysfunctions, Psychological
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- CRO1646
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoactive Sexual Desire Disorder
-
Federal University of Minas GeraisCompletedHypoactive Sexual Desire DisfunctionBrazil
-
University of British ColumbiaCompletedHypoactive Sexual Desire Disorder (HSDD)Canada
-
Warner ChilcottCompletedHypoactive Sexual Desire Disorder (HSDD)United States, Australia, Canada
-
Ivix LLXCompletedHypoactive Sexual Desire Disorder (HSDD)Russian Federation
-
Ivix LLXCompletedHypoactive Sexual Desire Disorder(HSDD)Russian Federation
-
EndoCeutics Inc.AMAG Pharmaceuticals, Inc.WithdrawnHypoactive Sexual Desire Disorder (HSDD)United States
-
S1 Biopharma, Inc.CompletedHypoactive Sexual Desire Disorder (DSM-IV-TR Defined) | Sexual Interest/Arousal Disorder (DSM-5 Defined)United States
-
TriHealth Inc.TriHealth Medical Education Research FundCompletedHypoactive Sexual Desire Disorder (HSDD) | Low Libido | Female Sexual Dysfunction (FSD)United States
-
Bezmialem Vakif UniversityUnknownMenopause | Hypoactive Sexual Desire Disorder | Sexual Desire DisorderTurkey
-
Ivix LLXCompletedFemale Sexual Dysfunction | Hypoactive Sexual Desire Disorder | Sexual Desire DisorderRussian Federation
Clinical Trials on Intrinsa Transdermal testosterone patch
-
VIVUS LLCTerminatedHypoactive Sexual Desire DisorderUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Warner ChilcottCompletedHypoactive Sexual Desire DisorderUnited States
-
Warner ChilcottCompletedEndometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal WomenHypoactive Sexual Desire DisorderUnited States
-
Warner ChilcottCompletedHypoactive Sexual Desire Disorder (HSDD)United States, Australia, Canada
-
Warner ChilcottCompletedHypoactive Sexual Desire DisorderAustralia
-
Warner ChilcottCompletedHypoactive Sexual Desire DisorderUnited States, Canada, Australia
-
VA Office of Research and DevelopmentKessler Institute for RehabilitationCompletedHypogonadism | Spinal Cord InjuryUnited States
-
BioSante PharmaceuticalsCompletedHypoactive Sexual Desire DisorderUnited States, Canada
-
Charles Drew University of Medicine and ScienceCompletedStress Urinary IncontinenceUnited States