Sexuality After Reduction Mammaplasty

NCT ID: NCT01020422

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexual Function Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Reduction mammaplasty

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Breast reduction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade do Vale do Sapucai

OTHER

Sponsor Role collaborator

Daniela Francescato Veiga

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniela Francescato Veiga

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Flavia N Beraldo, PhD

Role: PRINCIPAL_INVESTIGATOR

UNIFESP and UNIVAS

Daniela F Veiga, MD, PhD

Role: STUDY_DIRECTOR

UNIFESP and UNIVAS

Lydia M Ferreira, MD, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital das Clínicas Samuel Libânio - UNIVÁS

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26319082 (View on PubMed)

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.

Reference Type RESULT
PMID: 25536204 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Dinter 02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breast Reconstruction
NCT06332937 ACTIVE_NOT_RECRUITING