Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.

NCT04336891 | Completed

• 2 other identifiers: FEMENDO114457_oss
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

testosterone; female sexual dysfunction; genital vascularization; clitoris; dyspareunia

Outcome Measures

Primary Outcomes (3)

• Changes of clitoral artery peak systolic velocity (PSV) in women treated with testosterone gel

  parameter evaluated at clitoral color Doppler ultrasound

  6 months

• Changes of clitoral artery pulsatility index (PI) in women treated with testosterone gel

  parameter evaluated at clitoral color Doppler ultrasound

  6 months

• Changes of clitoral artery acceleration (ACC) in women treated with testosterone gel

  parameter evaluated at clitoral color Doppler ultrasound

  6 months

Secondary Outcomes (3)

• Difference in changes of clitoral artery PSV among the 4 intervention groups

  6 months

• Difference in changes of clitoral artery PI among the 4 intervention groups

  6 months

• Difference in changes of clitoral artery ACC among the 4 intervention groups

  6 months

Other Outcomes (4)

• Changes in Female Sexual Function Index (FSFI) Total, desire, arousal, lubrication, orgasm, satisfaction and pain scores, in women treated with transdermal Testosterone

  6 months

• Changes in serum total Testosterone levels in women treated with transdermal Testosterone

  6 months

• Changes in serum total Sex Hormone Binding Globulin (SHBG) levels in women treated with transdermal Testosterone

  6 months

Study Arms (4)

Hypoactive Sexual Desire Disorder

Women with Hypoactive Sexual Desire Disorder (HSDD, n=23)

Drug: Testosterone gel

Moderate to severe VVA

Women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA) (n=12)

Drug: Estradiol ovules

Mild to moderate VVA

Women with dyspareunia due to mild to moderate VVA (n=37)

Drug: Moisturizer

HSDD + VVA

Women with HSDD reporting also significant dyspareunia due to moderate to severe VVA (n=9).

Drug: Testosterone gel + Estradiol ovules

Interventions

Testosterone gel DRUG

Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day) for 6 months

Hypoactive Sexual Desire Disorder

Estradiol ovules DRUG

Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months

Moderate to severe VVA

Moisturizer DRUG

Local non-hormonal moisturizers applied regularly every 2-3 days and lubricants as needed

Mild to moderate VVA

Testosterone gel + Estradiol ovules DRUG

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

Also known as: Estradiol

HSDD + VVA

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pre- and postmenopausal women who attended our outpatient clinic at Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence (Florence, Italy) for sexual concerns.

You may qualify if:

• being heterosexual.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

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

Florence, 50136, Italy

Location

Related Publications (4)

• 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.

  PMID: 31263248 BACKGROUND

• 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.

  PMID: 29661689 BACKGROUND

• 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.

  PMID: 31498871 BACKGROUND

• Cipriani S, Maseroli E, Di Stasi V, Scavello I, Todisco T, Rastrelli G, Fambrini M, Sorbi F, Petraglia F, Jannini EA, Maggi M, Vignozzi L. Effects of testosterone treatment on clitoral haemodynamics in women with sexual dysfunction. J Endocrinol Invest. 2021 Dec;44(12):2765-2776. doi: 10.1007/s40618-021-01598-1. Epub 2021 Jun 12.

  PMID: 34118018 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Dyspareunia

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology; Chief of Andrology, Women's Endocrinology and Gender Incongruence, Careggi Hospital

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: March 20, 2019
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

IT (1)