Ultrasound and Psychobiological Correlates of Female Sexual Function

NCT ID: NCT02372643

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

clitoral, transvaginal and transrectal ultrasound

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Mario Maggi

Full Professor of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Maggi

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Locations

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Ambulatori di Medicina della Sessualità e Andrologia

Florence, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 18761595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21595833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20059655 (View on PubMed)

Other Identifiers

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ANDRO-AOUC-2015-01

Identifier Type: -

Identifier Source: org_study_id

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