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Sexuality After Reduction Mammaplasty

This study has been completed.
Sponsor:
Collaborator:
Universidade do Vale do Sapucai
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01020422
First received: November 20, 2009
Last updated: March 5, 2014
Last verified: March 2014

November 20, 2009
March 5, 2014
July 2008
November 2009   (final data collection date for primary outcome measure)
Sexual function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01020422 on ClinicalTrials.gov Archive Site
depression predictors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.
 
Completed
60
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
Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01020422
Dinter 02
No
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