At Melonga, we believe men deserve intimate health solutions backed by real clinical research, not vague promises or untested ideas. That’s why we conducted a sponsor-funded (but independent) randomised controlled clinical study to test whether Melonga works or not. The details of the study outlined below:
Excerpt from The German Clinical Trials Register (https://drks.de/search/en/trial/DRKS00032774)
https://de.melonga.com/climacs-studie/
The aim of the study is to determine the benefit of a digital intervention – the Melonga medical app – for better management of the symptoms of premature ejaculation (PE). The study aims to investigate the effects of a digital app-based intervention on PE symptoms and quality of life of PE patients.
This study aims to determine the usefulness of a digital intervention – the Melonga medical app – for better management of the symptoms of premature ejaculation (ICD-10: F52.4). PE is a highly stigmatized illness that affects up to 30% of all men. Despite the high level of suffering and sometimes severe psychological impairment, those affected rarely seek advice in a clinic or urological practice due to the social stigma. In the Premature Ejaculation Prevalence and Attitudes (PEPA) survey, only 9% of men with self-reported PE consulted a doctor. Doctors often feel uncomfortable discussing sexuality with their patients, usually due to embarrassment and a lack of training or expertise in treating EP. The primary therapies recommended today according to the EAU guidelines are drug treatment with the active ingredient dapoxetine or psychotherapy. Despite their proven effectiveness, both treatment options have disadvantages: With medication, the pill must be taken one to three hours before sexual intercourse. In addition, treatment with dapoxetine very often leads to side effects such as nausea, headaches and dizziness. Psychotherapeutic consultation is comparatively time-consuming and not always easy to integrate into the patient’s everyday life. In addition, the availability of therapists varies greatly from region to region and is not universal. Given the limitations of current means of treatments, the aim of this study is to evaluate clinical effectiveness of Melonga, a new digital app-based intervention for alleviating symptoms of premature ejaculation. The Melonga app offers patients non-drug and self-directed treatment of praecox ejaculation symptoms in the privacy of their own home through cognitive behavioral therapy methods. The Melonga app is a medical product (Class I according to MDR). The study is the first to examine the clinical and social value of a digital app-based intervention for the management of PE. The expected benefits of the intervention examined in this study are: 1) Improvement in premature ejaculation symptoms in patients 2) Improve patients’ quality of life 3) Improving patients’ sexual intimacy and improving their relationship with their partner. 4) Improve awareness of their medical condition, access to care and participation
1) Previous treatment with another preparation or intervention for EP within the last three months 2) Presence of sexual dysfunction other than EP (specifically erectile dysfunction with a current IIEF-5 < 22) . 3) Initiated treatment of sexual dysfunction other than EP in the last 4 weeks or intending to do so in the next 6 months. 4) History of symptoms of prostatitis or active inflammation in the urogenital area. 5) Psychiatric diseases requiring treatment with antidepressants from the SSRI group. 6) Physical function or mental impairment that prevents the participant from performing or understanding the required tasks of the study or completing the questionnaires. 7) Rejection of the study