CompletedPhase 4

Testosterone Patch's Effects on the Cardiovascular System and Libido

United Kingdom22 participantsStarted 2011-03

Plain-language summary

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.

Who can participate

Age range45 Years – 70 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Arterial Compliance - Augmentation Index

Timeframe: 12 weeks from baseline

Endothelial Function

Timeframe: 12 weeks from baseline

Trial details

NCT IDNCT01208038

SponsorImperial College Healthcare NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2019-05-16

View on ClinicalTrials.gov More Hypoactive Sexual Desire Disorder trials