An interventional study of cross-linked hyaluronic acid in Penile Girth Enhancement, sponsored by Biruni University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Biruni University · Not applicable, Interventional, and Other
The goal of this clinical trial is to learn how well HYAcorp MLF1, a hyaluronic acid filler, works for penile girth enhancement in men aged 25 years or older. The study will also learn about the safety of the treatment and how long its effect lasts.
The main questions it aims to answer are:
How much does average flaccid penile circumference change 6 months after treatment? What side effects or medical problems occur after treatment, and how long does the increase in penile girth last?
Participants will:
Receive one treatment with 20 mL of HYAcorp MLF1 Have penile circumference measured before treatment and during follow-up Complete questionnaires about satisfaction and sexual function Attend follow-up assessments for up to 12 months
This is a single-center, prospective, single-arm clinical study conducted at Biruni University Hospital. The study will include 65 male participants aged 25 years or older who are seeking penile girth enhancement and meet the eligibility criteria.
After written informed consent and baseline assessment, participants will receive a single 20 mL injection of HYAcorp MLF1, a cross-linked hyaluronic acid filler. The procedure will be performed under sterile conditions and local anesthesia using a blunt-tip cannula. The filler will be placed in the anatomical plane between the dartos fascia and Buck fascia.
Penile circumference will be measured in the flaccid state with the participant lying on his back under standardized conditions. Measurements will be taken at the distal, middle, and proximal penile shaft. The average of these three measurements will be used as the study measurement. Follow-up measurements will be performed by a clinician who did not perform the injection and who will not have access to procedural details.
The primary outcome is the change in average flaccid penile circumference from baseline to 6 months after treatment. Other assessments will include penile circumference at additional follow-up visits, participant-reported durability of the filler effect, satisfaction, erectile function, ejaculatory function, and safety.
Participants will be assessed shortly after the procedure, at approximately 7 and 30 days for safety, and at 3, 6, and 12 months for clinical follow-up. Adverse events will be recorded throughout the study. New participant enrollment will be temporarily stopped if a serious treatment-related or unexpected safety concern is identified.
Biruni University is the lead sponsor of 179 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Participants will receive a single 20 mL treatment with HYAcorp MLF1 for penile girth enhancement and will be followed for 12 months.
Device: cross-linked hyaluronic acid
Participants will receive a single 20 mL injection of HYAcorp MLF1, a cross-linked hyaluronic acid filler, under sterile conditions and local anesthesia. The filler will be administered using a blunt-tip cannula into the anatomical plane between the dartos fascia and Buck fascia, with the aim of achieving a homogeneous increase in penile girth.
Also known as: HYAcorp MLF1
Change From Baseline in Average Flaccid Penile Circumference at Month 6
Flaccid penile circumference will be measured in millimeters at the distal, middle, and proximal penile shaft using a non-stretch measuring tape under standardized conditions. The arithmetic mean of the three measurements will be recorded as the average flaccid penile circumference. Change will be calculated as the Month 6 value minus the baseline value.
Time frame: Baseline and Month 6
Change From Baseline in Average Flaccid Penile Circumference at Other Follow-up Time Points
Average flaccid penile circumference will be calculated as the arithmetic mean of distal, middle, and proximal shaft circumference measurements. Change at each follow-up time point will be calculated as the follow-up value minus the baseline value and reported in millimeters.
Time frame: Baseline, immediately after treatment, Month 3, and Month 12
Participant-Reported Residual Filler Durability Score
Participants will estimate the amount of residual filler using a 5-level ordinal scale: 0=no residual filler, 1=approximately 25% remaining, 2=approximately 50% remaining, 3=approximately 75% remaining, and 4=approximately 100% remaining. Higher scores indicate greater perceived filler durability.
Time frame: Month 3, Month 6, and Month 12
Change From Baseline in Penile Appearance Satisfaction Score
Penile appearance satisfaction will be rated on a 5-point ordinal scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied. Higher scores indicate greater satisfaction. Change will be calculated as the follow-up score minus the baseline score.
Time frame: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in Sexual Life Satisfaction Score
Sexual life satisfaction will be rated on a 5-point ordinal scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied. Higher scores indicate greater satisfaction. Change will be calculated as the follow-up score minus the baseline score.
Time frame: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
Erectile function will be assessed using the validated 5-item International Index of Erectile Function (IIEF-5). The total score ranges from 5 to 25, with higher scores indicating better erectile function and therefore a better outcome. Change from baseline will be calculated as the follow-up score minus the baseline score.
Time frame: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
Ejaculatory function will be assessed using the validated 5-item Premature Ejaculation Diagnostic Tool (PEDT). Total scores range from 0 to 20, with higher scores indicating a greater likelihood or severity of premature ejaculation. Change will be calculated as the follow-up score minus the baseline score.
Time frame: Baseline, Month 3, Month 6, and Month 12
Number of Participants With Adverse Events Through Month 12
Adverse events will be recorded according to onset, severity, relationship to treatment, and outcome. The number and proportion of participants experiencing adverse events will be summarized. Serious adverse events will be reported separately and described narratively.
Time frame: From treatment through Month 12
Inter-rater Reliability of Penile Circumference Measurements Assessed by Intraclass Correlation Coefficient
Agreement between two independent evaluators will be assessed using a two-way random-effects, absolute-agreement intraclass correlation coefficient \[ICC(2,1)\] with a 95% confidence interval.
Time frame: Month 12
Proportion of Participants Lost to Follow-up by Month 12
The number and proportion of enrolled participants who do not complete the planned follow-up through Month 12 will be reported.
Time frame: From enrollment through Month 12
Proportion of Participants Without Major Protocol Deviations
Protocol adherence will be assessed as the proportion of participants who complete the study without a major protocol deviation. The protocol-compliant analysis set will include participants without major protocol deviations.
Time frame: From enrollment through Month 12
Plan to share: No — Individual participant data are not planned to be shared because this study did not include a prespecified plan or mechanism for external sharing of de-identified participant-level data. Study findings will be reported in aggregate form.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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