Sexual FunctionNCT01020422
Sexuality After Reduction Mammaplasty
A study testing Reduction mammaplasty in people with Sexual Function and Depression, run by Daniela Francescato Veiga at 1 site in Brazil.
Trial summary
The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Function, Depression
- What is being tested?
- Reduction mammaplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- breast hypertrophy
- candidate to reduction mammaplasty
- healthy volunteer with normal volume breasts (control group)
- body mass index under 30Kg/m2
Who cannot join
- pregnancy, delivery or breast feeding during the last 12 months
- body mass index over 30Kg/m2
- breast cancer history
- previous breast surgery
- hard smoking
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, 37550000
About this study
Official title: Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty
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.
- Conditions
- Sexual Function, Depression
- Being tested
- Reduction mammaplasty
- Keywords
- breast hypertrophy, mammaplasty, sexuality, depression
- Medical subject headings
- Depression, Gigantomastia, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction mammaplastyProcedure or surgery
Also called Breast reduction
Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Reduction mammaplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual function
Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
Measured: 6 months
Secondary outcomes (1)
depression predictors
Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJul 2008
- Primary completionNov 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Francescato Veiga
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Responsible party
- Sponsor-investigator, Daniela Francescato Veiga, Federal University of São Paulo
- Investigators
- Flavia N Beraldo, PhD, Principal investigator, UNIFESP and UNIVASDaniela F Veiga, MD, PhD, Study director, UNIFESP and UNIVASLydia M Ferreira, MD, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020422
- Sponsor's protocol ID
- Dinter 02
- Status last verified
- Sep 2019
- First submitted
- 20 Nov 2009
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
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 26319082Beraldo 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty
- ClinicalTrials.gov ID
- NCT01020422
- Acronym / sponsor ID
- Dinter 02
- Conditions
- Sexual Function, Depression
- Keywords
- breast hypertrophy, mammaplasty, sexuality, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Daniela Francescato VeigaUniversity, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Study start
- Jul 2008 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Reduction mammaplastyBreast 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- breast hypertrophy
- candidate to reduction mammaplasty
- healthy volunteer with normal volume breasts (control group)
- body mass index under 30Kg/m2
Key exclusion criteria (5 listed)
- pregnancy, delivery or breast feeding during the last 12 months
- body mass index over 30Kg/m2
- breast cancer history
- previous breast surgery
- hard smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction mammaplastyAlso: Breast reductionSexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively. | Procedure or surgery | Reduction Mammaplasty |
Primary outcome
Sexual function
Time frame: 6 months
Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
1 secondary outcome
depression predictors
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 26319082Garcia 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.
- Results publication: PubMed 25536204Beraldo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction mammaplasty in people with Sexual Function and Depression, run by Daniela Francescato Veiga at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01020422, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.