Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.

Completed

• Conditions: Dyspareunia (Female Excluding Psychogenic); Hypoestrogenism; Arousal Disorders, Sexual; Hypoactive Sexual Desire Disorder; Menopause Related Conditions; Vulvovaginal Disease
• Interventions: Drug: Testosterone gel; Drug: Moisturizer; Drug: Testosterone gel + Estradiol ovules; Drug: Estradiol ovules

• Registration Number: NCT04336891
• Lead Sponsor: University of Florence

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study Start: 2019-03-20
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31
• Status Verified: 2020-04
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• being heterosexual.

Exclusion Criteria

• history of drug or alcohol abuse
• a diagnosis of uncontrolled or unstable mental or organic disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypoactive Sexual Desire Disorder	Testosterone gel	Women with Hypoactive Sexual Desire Disorder (HSDD, n=23)
Mild to moderate VVA	Moisturizer	Women with dyspareunia due to mild to moderate VVA (n=37)
HSDD + VVA	Testosterone gel + Estradiol ovules	Women with HSDD reporting also significant dyspareunia due to moderate to severe VVA (n=9).
Moderate to severe VVA	Estradiol ovules	Women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA) (n=12)

Primary Outcome Measures

Name	Time	Method
Changes of clitoral artery pulsatility index (PI) in women treated with testosterone gel	6 months	parameter evaluated at clitoral color Doppler ultrasound
Changes of clitoral artery peak systolic velocity (PSV) in women treated with testosterone gel	6 months	parameter evaluated at clitoral color Doppler ultrasound
Changes of clitoral artery acceleration (ACC) in women treated with testosterone gel	6 months	parameter evaluated at clitoral color Doppler ultrasound

Secondary Outcome Measures

Name	Time	Method
Difference in changes of clitoral artery PI among the 4 intervention groups	6 months
Difference in changes of clitoral artery PSV among the 4 intervention groups	6 months
Difference in changes of clitoral artery ACC among the 4 intervention groups	6 months

Trial Locations

Locations (1)

Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence, Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Florence, Italy