We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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):

Study Description
Brief Summary:
The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.

Condition or disease Intervention/treatment
Sexual Function Depression Procedure: Reduction mammaplasty

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : July 2008
Primary Completion Date : November 2009
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. depression predictors [ Time Frame: 6 months ]
    Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
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
More Information

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 Posted: November 25, 2009    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

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

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