Overview

This trial is active, not recruiting.

Condition healthy
Treatment clitoral, transvaginal and transrectal ultrasound
Sponsor University of Florence
Start date January 2015
End date January 2017
Trial size 20 participants
Trial identifier NCT02372643, ANDRO-AOUC-2015-01

Summary

Monocentric pilot interventional study. The aim of the study is to assess clitoral doppler ultrasonographic parameters in a population of sexually healthy volunteer women in order to obtain reference values. Psychobiological correlates of female sexual function will also be studied through hormonal testing and psychological evaluation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
20 sexually healthy volunteer women will be enrolled from subjects consulting our outpatient clinic (subjects free from sexual dysfunction). Hormonal and ultrasound parameters and self-administered questionnaires will be evaluated.
clitoral, transvaginal and transrectal ultrasound
Doppler Ultrasound assessment of clitoral hemodynamics will be performed in all subjects. Transvaginal and transrectal ultrasound will be performed in subjects giving their consent to these procedures.

Primary Outcomes

Measure
Clitoral artery peak systolic velocity and acceleration
time frame: baseline

Secondary Outcomes

Measure
Female sexual function assessed through the Female Sexual Function Index (FSFI)
time frame: baseline
General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ)
time frame: baseline
Body image is investigated through the Body Uneasiness Test (BUT)
time frame: baseline
Measurement of the thickness of the urethrovaginal space
time frame: baseline
Measurement of the thickness of the endometrial lining
time frame: baseline
Hormonal parameters (17β-estradiol, total testosterone, LH, FSH, TSH, PRL, delta-4-androstenedione, DHEAS, 17-Hydroxyprogesterone, SHBG)
time frame: baseline
Metabolic parameters (total cholesterol, HDL, triglycerides, glycemia, insulin, glycated hemoglobin)
time frame: baseline

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - sexually healthy - evidence of a personally signed and dated informed consent. Exclusion Criteria: - any uncontrolled or unstable, acute or chronic disease - alcohol or drugs abuse - sexual dysfunction - any overt psychiatric or psychological condition assessed through psychological evaluation and/or self-administered validated questionnaires.

Additional Information

Official title Pilot Interventional Study on Clitoral Ultrasound Measures and Psychobiological Correlates of Female Sexual Function
Principal investigator Mario Maggi
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Florence.