Male Intimate Harmonization MethodsNCT07901465
Male Intimate Harmonization: Efficacy, Satisfaction, and Safety
A study testing Botulinum toxin in people with Male Intimate Harmonization Methods, run by Antony Barbosa Institute at 1 site in Brazil.
Trial summary
Dissatisfaction with penile size and aesthetics may negatively affect men's self-esteem and quality of life, representing a relevant factor in psychological and sexual health. Intimate aesthetic procedures have increasingly been sought as an alternative to improve body perception and male confidence. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Intimate Harmonization Methods
- What is being tested?
- Botulinum toxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2026to 15 Aug 2026
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient database of the participating clinics, including individuals who have previously received care and expressed interest in the procedure.
- Volunteers recruited through the official website of the Antony Barbosa Institute using an electronic form.
- Justification: These channels were selected because they allow prior identification of individuals who have already sought aesthetic care or have a direct interest in the procedure, thereby reducing risks and ensuring adherence.
Who cannot join
- HIV/AIDS - Individuals living with HIV/AIDS may present:
- increased risk of delayed inflammation associated with dermal fillers;
- differences in inflammatory and healing responses;
- lack of robust studies evaluating the durability of injectable materials in immunosuppressed users.
- However, people living with HIV may participate in the study provided that they receive regular medical follow-up, have an undetectable viral load, and have a CD4+ T-lymphocyte count compatible with clinical stability, as assessed by the investigator physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Satisfaction, and Safety of Male Intimate Harmonization Methods: A Clinical Trial
Dissatisfaction with penile size and aesthetics may negatively affect men's self-esteem and quality of life, representing a relevant factor in psychological and sexual health. Intimate aesthetic procedures have increasingly been sought as an alternative to improve body perception and male confidence. Among the available techniques, the use of botulinum toxin and hyaluronic acid-based fillers has demonstrated potential to increase penile circumference and reduce the retraction reflex, providing functional and aesthetic benefits. However, the literature lacks robust studies evaluating the efficacy, safety, and psychological impact of these interventions.
The primary objective of this study is to evaluate the efficacy, safety, and level of satisfaction associated with male intimate harmonization methods using botulinum toxin and hyaluronic acid. In addition, the study aims to analyze the effects of these techniques on patients' self-esteem and body perception, particularly in individuals with small penis syndrome or anxiety related to penile size.
Read more
This is a prospective clinical trial. Participants will be selected according to predefined criteria and will undergo an initial evaluation by a urologist. On the first day, Dysport 300SU botulinum toxin will be administered along the length of the penis, with 60% of the volume concentrated near the base. Patients will use a penile extender for at least four hours per day until the follow-up visit, scheduled 15 days after administration. At this visit, measurements of penile length and circumference will be obtained in both flaccid and erect states, followed by the administration of hyaluronic acid for penile filling. The final evaluation will take place after 30 days for a new measurement of the parameters.
The procedures are expected to result in a significant increase in penile size and circumference, as well as improvements in body perception, self-esteem, and sexual satisfaction among participants. Furthermore, this study intends to contribute to the scientific evidence base regarding male intimate aesthetics by providing evidence on the safety and efficacy of the proposed techniques and assisting in the standardization of these interventions in clinical practice.
- Conditions
- Male Intimate Harmonization Methods
- Being tested
- Botulinum toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
Dysport® 300SU botulinum toxin will be administered along the entire length of the penis, with the amount administered proportional to penile size and circumference. The administration will be divided equally, with 60% of the total volume distributed within 1 cm of the penile base at anatomical points corresponding to the 10 and 2 o'clock, and 9 and 3 o'clock positions.
| Study group | Role | What they receive |
|---|---|---|
| Male Intimate Harmonization | Experimental | Participants will undergo a standardized male intimate harmonization protocol consisting of botulinum toxin administration followed by hyaluronic acid penile filling, with clinical, anthropometric, satisfaction, self-esteem, and safety assessments performed throughout the study follow-up period. Receives: Drug: Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in penile circumference
Change in penile circumference, measured in centimeters at the penile base, midpoint, and immediately below the glans, from D 0 to D 30 after the hyaluronic acid penile filling procedure. Measurements will be obtained in both flaccid and erect states.
Measured: Day 0 to Day 30 after the hyaluronic acid penile filling procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Apr 2026
- Primary completion31 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Intimate Harmonization MethodsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antony Barbosa Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antony de Paula Barbosa, Antony Barbosa Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901465
- Sponsor's protocol ID
- IAB.HIM.082026
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Satisfaction, and Safety of Male Intimate Harmonization Methods: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07901465
- Acronym / sponsor ID
- IAB.HIM.082026
- Conditions
- Male Intimate Harmonization Methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Antony Barbosa InstituteUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 28 Oct 2026 (actual)
- 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.
Dissatisfaction with penile size and aesthetics may negatively affect men's self-esteem and quality of life, representing a relevant factor in psychological and sexual health. Intimate aesthetic procedures have increasingly been sought as an alternative to improve body perception and male confidence. Among the available techniques, the use of botulinum toxin and hyaluronic acid-based fillers has demonstrated potential to increase penile circumference and reduce the retraction reflex, providing functional and aesthetic benefits. However, the literature lacks robust studies evaluating the efficacy, safety, and psychological impact of these interventions.
The primary objective of this study is to evaluate the efficacy, safety, and level of satisfaction associated with male intimate harmonization methods using botulinum toxin and hyaluronic acid. In addition, the study aims to analyze the effects of these techniques on patients' self-esteem and body perception, particularly in individuals with small penis syndrome or anxiety related to penile size.
This is a prospective clinical trial. Participants will be selected according to predefined criteria and will undergo an initial evaluation by a urologist. On the first day, Dysport 300SU botulinum toxin will be administered along the length of the penis, with 60% of the volume concentrated near the base. Patients will use a penile extender for at least four hours per day until the follow-up visit, scheduled 15 days after administration. At this visit, measurements of penile length and circumference will be obtained in both flaccid and erect states, followed by the administration of hyaluronic acid for penile filling. The final evaluation will take place after 30 days for a new measurement of the parameters.
The procedures are expected to result in a significant increase in penile size and circumference, as well as improvements in body perception, self-esteem, and sexual satisfaction among participants. Furthermore, this study intends to contribute to the scientific evidence base regarding male intimate aesthetics by providing evidence on the safety and efficacy of the proposed techniques and assisting in the standardization of these interventions in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male Intimate Harmonization | Experimental | Drug: Botulinum toxinParticipants will undergo a standardized male intimate harmonization protocol consisting of botulinum toxin administration followed by hyaluronic acid penile filling, with clinical, anthropometric, satisfaction, self-esteem, and safety assessments performed throughout the study follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient database of the participating clinics, including individuals who have previously received care and expressed interest in the procedure.
- Volunteers recruited through the official website of the Antony Barbosa Institute using an electronic form.
- Justification: These channels were selected because they allow prior identification of individuals who have already sought aesthetic care or have a direct interest in the procedure, thereby reducing risks and ensuring adherence.
Key exclusion criteria (5 listed)
- HIV/AIDS - Individuals living with HIV/AIDS may present:
- However, people living with HIV may participate in the study provided that they receive regular medical follow-up, have an undetectable viral load, and have a CD4+ T-lymphocyte count compatible with clinical stability, as assessed by the investigator physician.
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 |
|---|---|---|
| Botulinum toxinDysport® 300SU botulinum toxin will be administered along the entire length of the penis, with the amount administered proportional to penile size and circumference. The administration will be divided equally, with 60% of the total volume distributed within 1 cm of the penile base at anatomical points corresponding to the 10 and 2 o'clock, and 9 and 3 o'clock positions. | Drug | Male Intimate Harmonization |
Primary outcome
Change in penile circumference
Time frame: Day 0 to Day 30 after the hyaluronic acid penile filling procedure
Change in penile circumference, measured in centimeters at the penile base, midpoint, and immediately below the glans, from D 0 to D 30 after the hyaluronic acid penile filling procedure. Measurements will be obtained in both flaccid and erect states.
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 28 Oct 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin in people with Male Intimate Harmonization Methods, run by Antony Barbosa Institute 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 3 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 28 Oct 2026. 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?
Change in penile circumference (time frame: Day 0 to Day 30 after the hyaluronic acid penile filling procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.