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CompletedNCT01020422Updated Sep 6, 2019

Sexuality After Reduction Mammaplasty

An interventional study of Reduction mammaplasty in Sexual Function and Depression, sponsored by Daniela Francescato Veiga. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by Daniela Francescato Veiga · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jul 2008, registered Nov 2009).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Sexual Function
  • Depression

Keywords

  • breast hypertrophy
  • mammaplasty
  • sexuality
  • depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 60 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Daniela Francescato Veiga is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureReduction 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.

    Also known as: Breast reduction

06

What researchers measure

Primary outcomes

  1. Sexual function

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

    Time frame: 6 months

Secondary outcomes

  1. depression predictors

    Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.

    Time frame: 6 months

07

Study locations

1 site
  • Hospital das Clínicas Samuel Libânio - UNIVÁS
    Pouso Alegre, Minas Gerais 37550000, Brazil
08

References and documents

Publications

  • 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. PubMed 26319082 ↗
  • 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. PubMed 25536204 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01020422
Lead sponsor
Daniela Francescato Veiga
Collaborators
Universidade do Vale do Sapucai
Responsible party
Daniela Francescato Veiga (Professor, Federal University of São Paulo) — Sponsor-investigator
First posted
Nov 25, 2009
Start date
Jul 2008
Primary completion
Nov 2009
Completion
Sep 2011
Last update
Sep 6, 2019

Study contacts

Flavia N Beraldo, PhD
principal investigator · UNIFESP and UNIVAS
Daniela F Veiga, MD, PhD
study director · UNIFESP and UNIVAS
Lydia M Ferreira, MD, PhD
study chair · Federal University of São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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