Ultrasound and Psychobiological Correlates of Female Sexual Function

Sponsor

University of Florence (Other)

Overall Status

Unknown status

CT.gov ID

NCT02372643

Collaborator

(none)

Enrollment

Location

Arm

65.9

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: clitoral, transvaginal and transrectal ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Pilot Interventional Study on Clitoral Ultrasound Measures and Psychobiological Correlates of Female Sexual Function

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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

Female sexual function assessed through the Female Sexual Function Index (FSFI) [baseline]
General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ) [baseline]
See above
Body image is investigated through the Body Uneasiness Test (BUT) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.