Ultrasound and Psychobiological Correlates of Female Sexual Function
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|ClinicalTrials.gov Identifier: NCT02372643|
Recruitment Status : Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: clitoral, transvaginal and transrectal ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Interventional Study on Clitoral Ultrasound Measures and Psychobiological Correlates of Female Sexual Function|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Sexually healthy women
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.
Other: 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.
- Clitoral artery peak systolic velocity and acceleration [ Time Frame: baseline ]This will not be evaluated in different time frames but evaluated in order to assess reference values in sexually healthy women and compared with subjects with sexual dysfunction.
- 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 ]See above
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372643
|Ambulatori di Medicina della Sessualità e Andrologia|
|Principal Investigator:||Mario Maggi||University of Florence|