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Sexuality After Reduction Mammaplasty

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.
ClinicalTrials.gov Identifier: NCT01020422
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : March 7, 2014
Information provided by (Responsible Party):

November 20, 2009
November 25, 2009
March 7, 2014
July 2008
November 2009   (Final data collection date for primary outcome measure)
Sexual function [ Time Frame: 6 months ]
Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
Sexual function index [ Time Frame: 0, 3 and 6 months ]
Complete list of historical versions of study NCT01020422 on ClinicalTrials.gov Archive Site
depression predictors [ Time Frame: 6 months ]
Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.
depression predictors [ Time Frame: 0, 3 and 6 months ]
Not Provided
Not Provided
Sexuality After Reduction Mammaplasty
Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty
The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.
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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Sexual Function
  • Depression
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
  • 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
    Intervention: Procedure: Reduction mammaplasty
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2011
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Dinter 02
Not Provided
Not Provided
Daniela Francescato Veiga, Federal University of São Paulo
Daniela Francescato Veiga
Universidade do Vale do Sapucai
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
Federal University of São Paulo
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP