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Sexuality After Reduction Mammaplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020422
First Posted: November 25, 2009
Last Update Posted: March 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Universidade do Vale do Sapucai
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
  Purpose
The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.

Condition Intervention
Sexual Function Depression Procedure: Reduction mammaplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty

Resource links provided by NLM:


Further study details as provided by Daniela Francescato Veiga, Federal University of São Paulo:

Primary Outcome Measures:
  • Sexual function [ Time Frame: 6 months ]
    Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.


Secondary Outcome Measures:
  • depression predictors [ Time Frame: 6 months ]
    Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.


Enrollment: 60
Study Start Date: July 2008
Study Completion Date: September 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Breast hypertrophy
Patients with macromastia will be evaluated in regard to sexual function and depression predictors at 3 moments: initial interview, after 3 months and after 6 months
Experimental: Reduction Mammaplasty
Breast hypertrophy patients randomized to this group will immediately be scheduled for reduction mammaplasty and will be will be evaluated in regard to sexual function and depression predictors preoperatively and 3 and 6 months postoperatively
Procedure: Reduction mammaplasty
Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
Other Name: Breast reduction

Detailed Description:
Breast hypertrophy is a common condition among women. Reduction mammaplasty is an effective and well established procedure performed for the relief discomfort associated with breast hypertrophy. Female breasts play an important role in sexuality, thus, the main purpose of this study is to determine whether reduction mammaplasty could influence sexual function and depression predictors on women with breast hypertrophy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • breast hypertrophy
  • candidate to reduction mammaplasty
  • healthy volunteer with normal volume breasts (control group)
  • body mass index under 30Kg/m2

Exclusion Criteria:

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • hard smoking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020422


Locations
Brazil
Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
Daniela Francescato Veiga
Universidade do Vale do Sapucai
Investigators
Principal Investigator: Flavia N Beraldo, MSC UNIFESP and UNIVAS
Study Director: Daniela F Veiga, MD, PhD UNIFESP and UNIVAS
Study Chair: Lydia M Ferreira, MD, PhD Federal University of São Paulo
  More Information

Publications:
Beraldo FN, Veiga DF, Veiga-Filho J,Vilas-Boas GS, Sabino-Neto M, Garcia EB, Juliano Y,Ferreira LM. Sexual function and depression outcomes in breast hypertrophy patients undergoing reduction mammaplasty: A randomized clinical trial. Journal of Women's Health 21(4):30, 2012. DOI: 10.1089/jwh.2012.Ab01

Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01020422     History of Changes
Other Study ID Numbers: Dinter 02
First Submitted: November 20, 2009
First Posted: November 25, 2009
Last Update Posted: March 7, 2014
Last Verified: March 2014

Keywords provided by Daniela Francescato Veiga, Federal University of São Paulo:
breast hypertrophy
mammaplasty
sexuality
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders