NCT02372643

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

February 12, 2015

Last Update Submit

March 24, 2020

Conditions

Healthy

Keywords

clitorissexualityvascularizationdopplerultrasoundreferencefemalePilot ProjectsVagina/ultrasonographyUrethra/ultrasonographyRegional Blood Flow/physiologyArteries/ultrasonographyClitoris/ultrasonographyReference valuesClitoris/blood supply

Outcome Measures

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.

    baseline

Secondary Outcomes (7)

  • Female sexual function assessed through the Female Sexual Function Index (FSFI)

    baseline

  • General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ)

    baseline

  • Body image is investigated through the Body Uneasiness Test (BUT)

    baseline

  • Measurement of the thickness of the urethrovaginal space

    baseline

  • Measurement of the thickness of the endometrial lining

    baseline

  • +2 more secondary outcomes

Study Arms (1)

Sexually healthy women

OTHER

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

clitoral, transvaginal and transrectal ultrasoundOTHER

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.

Sexually healthy women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatori di Medicina della Sessualità e Andrologia

Florence, Italy

Location

Related Publications (3)

  • 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.

    PMID: 18761595BACKGROUND

  • 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.

    PMID: 21595833BACKGROUND

  • 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.

    PMID: 20059655BACKGROUND

MeSH Terms

Conditions

SexualityNeovascularization, Pathologic

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mario Maggi

    University of Florence

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Endocrinology

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 26, 2015

Study Start

January 1, 2015

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

IT(1)