Effect of transdermal testosterone on the coagulation cascade.
Research type
Research Study
Full title
Evaluating the effect of transdermal testosterone on the coagulation cascade, vascular elasticity, and lipid profiles in naturally menopausal women.
IRAS ID
229620
Contact name
Haitham Hamoda
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Background:
It is accepted there is an age-related decline in sexual function in women, possibly representing an evolutionary change. The extent to which this decline in function impacts upon an individual is extremely heterogeneous, and therefore establishing normal parameters presents a significant clinical challenge. Given our ageing population, there is a greater emphasis on understanding sexual function and the underlying patho-physiology that may give rise to dysfunction.
The Diagnostic and Statistical Manual of Mental Disorders (5th Edition), DSM–5 in 2013 formed a new diagnostic definition for female sexual dysfunction. By combining HSDD with Female Sexual Arousal Disorder (FSAD), a diagnosis of Female Sexual Interest/Arousal Disorder (FSIAD) was established.
Given the wide-reaching implications of FSIAD, women may seek treatment for a variety of reasons and androgen therapy remains the predominant option. Androgens play an important role in healthy female sexual function, especially in stimulating libido and sexual interest and in maintaining desire. The decline in androgen concentration in relation to sexual function is still unclear, however treatment with exogenous androgen therapy has proven fruitful and
continues to be a field requiring further investigation.One such area of study is to determine the impact on the coagulation cascade of exogenous androgen therapy. Using biochemical markers of hypercoagulability, namely thrombin generation it it possible to examine the effect of a particular method of hormone replacement therapy on thrombotic risk. We seek to determine whether the addition of androgen therapy to a HRT regimen, results in this change in symptomatic postmenopausal women.
Aims
To assess the effect of transdermal testosterone, when used in combination with HRT in the form of transdermal oestradiol and micronised progesterone, on the coagulation cascade, cardiovascular system and lipid profile in naturally menopausal women.
REC name
Wales REC 6
REC reference
17/WA/0400
Date of REC Opinion
5 Dec 2017
REC opinion
Favourable Opinion