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Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.

NCT04336891 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2020-04-07

No results posted yet for this study

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

Interventions

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

DRUG

Estradiol ovules

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

DRUG

Moisturizer

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

DRUG

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

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2019-12-31
Completion
2020-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04336891 on ClinicalTrials.gov