Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
The regulation of clitoral vascularization by sex steroids is still under-investigated. We
aimed to explore the effects of 6 months transdermal Testosterone (T) therapy on clitoral
color Doppler ultrasound (CDU) parameters in pre- and postmenopausal women with female sexual
dysfunction (FSD). In order to do that, we retrospectively recruited n=81 women with FSD,
divided into 4 groups according to different treatments followed as per clinical practice,
for 6 months: transdermal systemic 2% T gel; local estradiol ovules; local non-hormonal
moisturizers; transdermal T plus local estrogens.
Our main hypothesis is that systemic T treatment is able to positively modulate clitoral
blood flow in basal conditions, specifically to increase clitoral artery Peak systolic
velocity (PSV).
Strong clinical evidence supports the use of transdermal systemic testosterone (T) treatment
for Hypoactive Sexual Desire Disorder (HSDD) in menopausal women. According to preclinical
studies, T is necessary to maintain the functional machinery underlying clitoral arousal
response. In hypogonadal men with erectile dysfunction, T replacement therapy is able to
improve penile vasodilation as assessed by using color Doppler ultrasound (CDU). On the other
hand, the regulation of clitoral vascularization by sex steroids is still under-investigated.
We aimed to explore the effects of 6 months T therapy on clitoral CDU parameters and sexual
function in pre- and postmenopausal women with female sexual dysfunction (FSD).
Adult heterosexual women attending our clinic for sexual concerns were retrospectively
recruited. A subgroup of sexually active patients with FSD (n=81) was divided into 4
different groups according to different treatments followed as per clinical practice: women
with Hypoactive Sexual Desire Disorder (HSDD) treated with off-label transdermal 2% T gel
once daily (300 mcg T per day, n=23); women with dyspareunia due to moderate to severe
vulvovaginal atrophy (VVA), treated with local estrogens (estradiol ovules) taken daily for 2
weeks and afterwards twice a week (n=12); women with dyspareunia due to mild to moderate VVA,
treated with non-hormonal moisturizers every 2-3 days (n=37); women with HSDD reporting also
significant dyspareunia due to moderate to severe VVA, treated with combined therapy
(transdermal T and local estrogens) (n=9). Patients underwent physical, laboratory, uterine
and genital (clitoral and uterine arteries) CDU examinations, and completed the Female Sexual
Function Index (FSFI). at baseline and after 6 months.
Our main hypothesis is that systemic T treatment is able to positively modulate clitoral
blood flow in basal conditions, specifically to increase clitoral artery Peak systolic
velocity (PSV).
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