Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.

Hypoactive Sexual Desire Disorder Clinical Trial

— TESTOFSD  

Official title:

Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336891
• Other study ID #: FEMENDO1
• Secondary ID: 14457_oss
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• being heterosexual.

Exclusion Criteria:

• history of drug or alcohol abuse

• a diagnosis of uncontrolled or unstable mental or organic disease.

Related Conditions & MeSH terms

• Arousal Disorders, Sexual
• Disease
• Dyspareunia
• Dyspareunia (Female Excluding Psychogenic)
• Hypoactive Sexual Desire Disorder
• Hypoestrogenism
• Menopause Related Conditions
• Sexual Dysfunctions, Psychological
• Vulvovaginal Disease

Intervention

Drug:
• Testosterone gel
Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day) for 6 months
• Estradiol ovules
Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months
• Moisturizer
Local non-hormonal moisturizers applied regularly every 2-3 days and lubricants as needed
• Testosterone gel + Estradiol ovules
Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day), plus Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months

Locations

Country	Name	City	State
Italy	Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence, Azienda Ospedaliero-Universitaria Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Davis SR, Baber R, Panay N, Bitzer J, Perez SC, Islam RM, Kaunitz AM, Kingsberg SA, Lambrinoudaki I, Liu J, Parish SJ, Pinkerton J, Rymer J, Simon JA, Vignozzi L, Wierman ME. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4660-4666. doi: 10.1210/jc.2019-01603. — View Citation

Maseroli E, Scavello I, Vignozzi L. Cardiometabolic Risk and Female Sexuality-Part II. Understanding (and Overcoming) Gender Differences: The Key Role of an Adequate Methodological Approach. Sex Med Rev. 2018 Oct;6(4):525-534. doi: 10.1016/j.sxmr.2018.03.004. Epub 2018 Apr 13. Review. — View Citation

Scavello I, Maseroli E, Di Stasi V, Cipriani S, Verde N, Magini A, Maggi M, Vignozzi L. Nomegestrol acetate/17beta-estradiol does not negatively alter the vascular resistance of clitoral arteries: a prospective, exploratory study. Int J Impot Res. 2020 Mar;32(2):239-247. doi: 10.1038/s41443-019-0162-7. Epub 2019 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Female Sexual Function Index (FSFI) Total, desire, arousal, lubrication, orgasm, satisfaction and pain scores, in women treated with transdermal Testosterone		6 months
Other	Changes in serum total Testosterone levels in women treated with transdermal Testosterone	Women were asked to have blood samples drawn in the morning, after an overnight fast, during the early follicular phase (if premenopausal)	6 months
Other	Changes in serum total Sex Hormone Binding Globulin (SHBG) levels in women treated with transdermal Testosterone	Women were asked to have blood samples drawn in the morning, after an overnight fast, during the early follicular phase (if premenopausal)	6 months
Other	Difference in changes of - Total cholesterol, high-density lipoprotein cholesterol, triglycerides, glycated hemoglobin, fasting glucose and insulin levels among the 4 intervention groups	Women were asked to have blood samples drawn in the morning, after an overnight fast	6 months
Primary	Changes of clitoral artery peak systolic velocity (PSV) in women treated with testosterone gel	parameter evaluated at clitoral color Doppler ultrasound	6 months
Primary	Changes of clitoral artery pulsatility index (PI) in women treated with testosterone gel	parameter evaluated at clitoral color Doppler ultrasound	6 months
Primary	Changes of clitoral artery acceleration (ACC) in women treated with testosterone gel	parameter evaluated at clitoral color Doppler ultrasound	6 months
Secondary	Difference in changes of clitoral artery PSV among the 4 intervention groups		6 months
Secondary	Difference in changes of clitoral artery PI among the 4 intervention groups		6 months
Secondary	Difference in changes of clitoral artery ACC among the 4 intervention groups		6 months