NCT01020422

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

November 20, 2009

Last Update Submit

September 3, 2019

Conditions

Sexual FunctionDepression

Keywords

breast hypertrophymammaplastysexualitydepression

Outcome Measures

Primary Outcomes (1)

  • Sexual function

    Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.

    6 months

Secondary Outcomes (1)

  • depression predictors

    6 months

Study Arms (2)

Breast hypertrophy

NO INTERVENTION

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

Reduction Mammaplasty

EXPERIMENTAL

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

Interventions

Reduction mammaplastyPROCEDURE

Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.

Also known as: Breast reduction
Reduction Mammaplasty

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • pregnancy, delivery or breast feeding during the last 12 months
  • body mass index over 30Kg/m2
  • breast cancer history
  • previous breast surgery
  • hard smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas Samuel Libânio - UNIVÁS

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Related Publications (2)

  • Garcia ES, Veiga DF, Sabino-Neto M, Beraldo Cardoso FN, Batista IO, Leme RM, Cabral IV, Novo NF, Ferreira LM. Sensitivity of the Nipple-Areola Complex and Sexual Function Following Reduction Mammaplasty. Aesthet Surg J. 2015 Sep;35(7):NP193-202. doi: 10.1093/asj/sjv034.

    PMID: 26319082BACKGROUND

  • Beraldo FN, Veiga DF, Veiga-Filho J, Garcia ES, Vilas-Boas GS, Juliano Y, Sabino-Neto M, Ferreira LM. Sexual Function and Depression Outcomes Among Breast Hypertrophy Patients Undergoing Reduction Mammaplasty: A Randomized Controlled Trial. Ann Plast Surg. 2016 Apr;76(4):379-82. doi: 10.1097/SAP.0000000000000380.

    PMID: 25536204RESULT

MeSH Terms

Conditions

DepressionGigantomastiaSexuality

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSexual Behavior

Study Officials

  • Flavia N Beraldo, PhD

    UNIFESP and UNIVAS

    PRINCIPAL INVESTIGATOR

  • Daniela F Veiga, MD, PhD

    UNIFESP and UNIVAS

    STUDY DIRECTOR

  • Lydia M Ferreira, MD, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 25, 2009

Study Start

July 1, 2008

Primary Completion

November 1, 2009

Study Completion

September 1, 2011

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

BR(1)