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NCT07877077

HYAcorp MLF1 Hyaluronic Acid Filler for Penile Girth Enhancement

Sponsor: Biruni University

View on ClinicalTrials.gov

Summary

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

Official title: Evaluation of the Efficacy, Safety, and Durability of Cross-Linked Hyaluronic Acid Body Filler HYAcorp MLF1 for Penile Girth Enhancement

Key Details

Gender

MALE

Age Range

25 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2027-12

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Penile Girth Enhancement

Interventions

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.

Inclusion Criteria: * Male participants aged 25 years or older. * Seeking penile girth enhancement at the urology clinic. * Able to understand the study procedures and the potential benefits and risks. * Able and willing to provide written informed consent. * Willing to attend the planned follow-up visits at 3, 6, and 12 months. * No active genital condition identified during the baseline urological examination that would prevent participation in the study. Exclusion Criteria: * Uncontrolled diabetes mellitus or glycated hemoglobin (HbA1c) greater than 6.5%. * Active urinary tract infection, genital skin infection, active herpes lesion, or inflammatory skin disease at the treatment site. * History of penile surgery other than circumcision, including penile prosthesis surgery, reconstructive surgery, or surgery following penile trauma. * Penile filler treatment within the previous 2 years. * Congenital or acquired penile abnormality, including Peyronie's disease, micropenis, severe phimosis, or significant penile deformity. * History of a serious complication related to any previous filler treatment, including soft tissue infection requiring hospitalization or surgery, anaphylaxis, thromboembolic event, necrosis, or severe hypersensitivity reaction. * Known serious allergy to hyaluronic acid, local anesthetics, or planned prophylactic or analgesic medications. * Coagulopathy, uncontrolled use of anticoagulant or antiplatelet medication, or another clinical condition associated with increased bleeding risk. * Major systemic disease, advanced immunosuppression, active malignancy, or another clinical condition considered by the investigator to increase the risk of the procedure. * Suspected body dysmorphic disorder, unrealistic expectations, or severe anxiety or depression requiring psychiatric evaluation. * Participation in another interventional clinical study within the previous 30 days. * Social, cognitive, or logistical circumstances that would prevent adherence to the study protocol.

Locations (1)

Biruni University Faculty of Medicine Hospital

Istanbul, Küçükçekmece, Turkey (Türkiye)