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Status unknownNCT02372643Updated Mar 26, 2020

Ultrasound and Psychobiological Correlates of Female Sexual Function

An interventional study of clitoral, transvaginal and transrectal ultrasound in Healthy, sponsored by University of Florence. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by University of Florence · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • 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
03

In context

Sexuality

30 studies on the registry are indexed under Sexuality; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 63 across 16 interventional studies indexed under Sexuality.

Browse Sexuality studies →

Lead sponsor

University of Florence is the lead sponsor of 76 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • sexually healthy
  • evidence of a personally signed and dated informed consent.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

Secondary outcomes

  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)

    See above

    Time frame: baseline

  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

07

Study locations

1 site
  • Ambulatori di Medicina della Sessualità e Andrologia
    Florence, Italy
08

References and documents

Publications

  • 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. PubMed 18761595 ↗
  • 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. PubMed 21595833 ↗
  • 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. PubMed 20059655 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02372643
Lead sponsor
University of Florence
Responsible party
Mario Maggi (Full Professor of Endocrinology, University of Florence) — Principal investigator
First posted
Feb 26, 2015
Start date
Jan 2015
Primary completion
Dec 31, 2019
Completion
Jun 30, 2020 (estimated)
Last update
Mar 26, 2020

Study contacts

Mario Maggi
principal investigator · University of Florence

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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