Ultrasound and Psychobiological Correlates of Female Sexual Function

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02372643
• Other study ID #: ANDRO-AOUC-2015-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2020
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Italy	Ambulatori di Medicina della Sessualità e Andrologia	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clitoral artery peak systolic velocity and acceleration	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.	baseline
Secondary	Female sexual function assessed through the Female Sexual Function Index (FSFI)		baseline
Secondary	General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ)	See above	baseline
Secondary	Body image is investigated through the Body Uneasiness Test (BUT)		baseline
Secondary	Measurement of the thickness of the urethrovaginal space		baseline
Secondary	Measurement of the thickness of the endometrial lining		baseline
Secondary	Hormonal parameters (17ß-estradiol, total testosterone, LH, FSH, TSH, PRL, delta-4-androstenedione, DHEAS, 17-Hydroxyprogesterone, SHBG)		baseline
Secondary	Metabolic parameters (total cholesterol, HDL, triglycerides, glycemia, insulin, glycated hemoglobin)		baseline