Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
NCT ID: NCT04336891
Last Updated: 2020-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2019-03-20
2020-03-31
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Hypoactive Sexual Desire Disorder
Women with Hypoactive Sexual Desire Disorder (HSDD, n=23)
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
Moderate to severe VVA
Women with dyspareunia due to moderate to severe vulvovaginal atrophy (VVA) (n=12)
Estradiol ovules
Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months
Mild to moderate VVA
Women with dyspareunia due to mild to moderate VVA (n=37)
Moisturizer
Local non-hormonal moisturizers applied regularly every 2-3 days and lubricants as needed
HSDD + VVA
Women with HSDD reporting also significant dyspareunia due to moderate to severe VVA (n=9).
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* a diagnosis of uncontrolled or unstable mental or organic disease.
18 Years
FEMALE
No
Sponsors
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University of Florence
OTHER
Responsible Party
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Linda Vignozzi, MD
Associate Professor of Endocrinology; Chief of Andrology, Women's Endocrinology and Gender Incongruence, Careggi Hospital
Locations
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Andrology, Women's Endocrinology and Gender Incongruence Unit, University of Florence, Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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14457_oss
Identifier Type: OTHER
Identifier Source: secondary_id
FEMENDO1
Identifier Type: -
Identifier Source: org_study_id
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