Ultrasound and Psychobiological Correlates of Female Sexual Function

Not Applicable

• Conditions: Healthy
• Interventions: Other: clitoral, transvaginal and transrectal ultrasound

• Registration Number: NCT02372643
• Lead Sponsor: University of Florence

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-02-26
• Primary Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sexually healthy women	clitoral, transvaginal and transrectal ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Clitoral artery peak systolic velocity and acceleration	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ambulatori di Medicina della Sessualità e Andrologia; 🇮🇹 Florence, Italy