Clinical trial NCT02372643: Ultrasound and Psychobiological Correlates of Female Sexual Function
Official title: Pilot Interventional Study on Clitoral Ultrasound Measures and Psychobiological Correlates of Female Sexual Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Clitoral artery peak systolic velocity and acceleration
timeFrame: baseline
Secondary outcomes:
measure: Female sexual function assessed through the Female Sexual Function Index (FSFI)
timeFrame: baseline
measure: General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ)
timeFrame: baseline
measure: Body image is investigated through the Body Uneasiness Test (BUT)
timeFrame: baseline
measure: Measurement of the thickness of the urethrovaginal space
timeFrame: baseline
measure: Measurement of the thickness of the endometrial lining
timeFrame: baseline
measure: Hormonal parameters (17β-estradiol, total testosterone, LH, FSH, TSH, PRL, delta-4-androstenedione, DHEAS, 17-Hydroxyprogesterone, SHBG)
timeFrame: baseline
measure: Metabolic parameters (total cholesterol, HDL, triglycerides, glycemia, insulin, glycated hemoglobin)
timeFrame: baseline
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Ambulatori di Medicina della Sessualità e Andrologia
Study officials:
affiliation: University of Florence
name: Mario Maggi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battaglia C, Nappi RE, Mancini F, Cianciosi A, Persico N, Busacchi P, Facchinetti F, de Aloysio D. Menstrual cycle-related morphometric and vascular modifications of the clitoris. J Sex Med. 2008 Dec;5(12):2853-61. doi: 10.1111/j.1743-6109.2008.00972.x. Epub 2008 Aug 28.
citation: Battaglia C, Battaglia B, Mancini F, Nappi RE, Paradisi R, Venturoli S. Moderate alcohol intake, genital vascularization, and sexuality in young, healthy, eumenorrheic women. A pilot study. J Sex Med. 2011 Aug;8(8):2334-43. doi: 10.1111/j.1743-6109.2011.02310.x. Epub 2011 May 19.
citation: Battaglia C, Nappi RE, Mancini F, Alvisi S, Del Forno S, Battaglia B, Venturoli S. PCOS and urethrovaginal space: 3-D volumetric and vascular analysis. J Sex Med. 2010 Aug;7(8):2755-64. doi: 10.1111/j.1743-6109.2009.01651.x. Epub 2010 Jan 6.