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
|Condition or disease||Intervention/treatment||Phase|
|Sexual Function Depression||Procedure: Reduction mammaplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||September 2011|
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
- Sexual function [ Time Frame: 6 months ]Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
- depression predictors [ Time Frame: 6 months ]Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.
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|
|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|