Hypoactive Sexual Desire Disorder Clinical Trial
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.
NCT number | NCT01208038 |
Other study ID # | CRO1646 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2011 |
Est. completion date | February 2012 |
Verified date | December 2019 |
Source | Imperial College Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 70 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital | London | |
United Kingdom | Queen Charlotte's and Chelsea Hospital | London | |
United Kingdom | Royal Brompton Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust | Chelsea and Westminster NHS Foundation Trust, Royal Brompton & Harefield NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arterial Compliance - Augmentation Index | 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 | |
Primary | Endothelial Function | 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 | Insulin Resistance - HOMA-IR | 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 | |
Secondary | Libido - B-PFSF Score | 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 |
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