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Ultrasound and Psychobiological Correlates of Female Sexual Function

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02372643
Enrollment
20
Registered
2015-02-26
Start date
2015-01-31
Completion date
2020-06-30
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

clitoris, sexuality, vascularization, doppler, ultrasound, reference, female, Pilot Projects, Vagina/ultrasonography, Urethra/ultrasonography, Regional Blood Flow/physiology, Arteries/ultrasonography, Clitoris/ultrasonography, Reference values, Clitoris/blood supply

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.

Interventions

OTHERclitoral, 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.

Sponsors

University of Florence
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Clitoral artery peak systolic velocity and accelerationbaselineThis 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

MeasureTime frameDescription
General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ)baselineSee above
Body image is investigated through the Body Uneasiness Test (BUT)baseline
Measurement of the thickness of the urethrovaginal spacebaseline
Female sexual function assessed through the Female Sexual Function Index (FSFI)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
Measurement of the thickness of the endometrial liningbaseline

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026