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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
Sponsor:
Information provided by (Responsible Party):
Mario Maggi, 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.

Condition or disease Intervention/treatment Phase
Healthy Other: clitoral, transvaginal and transrectal ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2015
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Female sexual function assessed through the Female Sexual Function Index (FSFI) [ Time Frame: baseline ]
  2. General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ) [ Time Frame: baseline ]
    See above

  3. Body image is investigated through the Body Uneasiness Test (BUT) [ Time Frame: baseline ]
  4. Measurement of the thickness of the urethrovaginal space [ Time Frame: baseline ]
  5. Measurement of the thickness of the endometrial lining [ Time Frame: baseline ]
  6. Hormonal parameters (17β-estradiol, total testosterone, LH, FSH, TSH, PRL, delta-4-androstenedione, DHEAS, 17-Hydroxyprogesterone, SHBG) [ Time Frame: baseline ]
  7. Metabolic parameters (total cholesterol, HDL, triglycerides, glycemia, insulin, glycated hemoglobin) [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Italy
Ambulatori di Medicina della Sessualità e Andrologia
Florence, Italy
Sponsors and Collaborators
University of Florence
Investigators
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Principal Investigator: Mario Maggi University of Florence
Publications:
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Responsible Party: Mario Maggi, Full Professor of Endocrinology, University of Florence
ClinicalTrials.gov Identifier: NCT02372643    
Other Study ID Numbers: ANDRO-AOUC-2015-01
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Keywords provided by Mario Maggi, University of Florence:
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