> ## Documentation Index > Fetch the complete documentation index at: https://docs.hi-doctor.ai/llms.txt > Use this file to discover all available pages before exploring further. # Bremelanotide > Why bremelanotide (Vyleesi) has no EU authorisation, what the RECONNECT trials reported, and what a Hi-Doctor doctor can review instead. Bremelanotide, sold in the United States as Vyleesi, is an injection given under the skin of the stomach or thigh about 45 minutes before sex. It has no marketing authorisation in the European Union, so no EU doctor — including a Hi-Doctor doctor — can prescribe it. Bremelanotide has no EU marketing authorisation. It cannot legally be prescribed or dispensed by any doctor working in the EU, and Hi-Doctor does not offer it. ## What it is Bremelanotide is for premenopausal women with persistently low sexual desire that causes them real distress — a diagnosis doctors call hypoactive sexual desire disorder (HSDD). It works on desire signals in the brain, so it is nothing like the tablets men take for erection problems, and it is not meant to improve sexual performance. It is a **melanocortin receptor agonist**: it acts on signalling pathways in the brain involved in sexual desire, rather than on blood flow to the genitals. ## Regulatory status Bremelanotide is approved in the United States but has no marketing authorisation in the European Union. As of a check of the EMA public medicines register on 27 July 2026, there is no entry for bremelanotide or Vyleesi as an authorised, refused or withdrawn application. An EU authorisation gap is not the same as a safety concern. It means the medicine has not been through, or has not completed, the EU regulatory process — so it sits outside what any EU-licensed doctor is permitted to prescribe. ## What the studies reported The RECONNECT phase 3 trials (Kingsberg et al., *Obstetrics & Gynecology*, 2019) enrolled 1,267 women. Two registry entries cover this programme: [NCT02333071](https://clinicaltrials.gov/study/NCT02333071) and [NCT02338960](https://clinicaltrials.gov/study/NCT02338960). A few things are worth knowing about who was studied: 96.6% of participants were recruited at US sites, and 85.6% were white. The differences from placebo were small movements on questionnaire scales whose day-to-day meaning is debated. | Effect | Bremelanotide | Placebo | | -------- | ------------- | ------- | | Nausea | 40.0% | 1.3% | | Flushing | 20.3% | 0.3% | Every NCT identifier links to its ClinicalTrials.gov record. A trial readout is not the same as a peer-reviewed publication — the primary source here is Kingsberg et al., *Obstet Gynecol* 2019, alongside the US FDA prescribing information for VYLEESI (via DailyMed) and the 2019 FDA-approved label. ## If low desire is the concern A GP or gynaecologist can look at hormones, mood, medication side effects and relationship factors together, which is the assessment low desire actually needs. Within Hi-Doctor's sexual health consultation, doctors review the case that is actually submitted and consider the EU-authorised options that fit it — see [low sexual desire](/library/conditions/low-libido) for how that consultation works. Where a related PDE5-inhibitor question comes up in a sexual health case (for a different indication, such as erectile dysfunction), the options a Hi-Doctor doctor can assess include [sildenafil](/library/medicines/viagra) and other authorised tablets in that class — none of which treat HSDD, and a doctor decides case by case whether any of them are relevant to what was actually reported in the questionnaire. ## Common questions Bremelanotide is for premenopausal women with persistently low sexual desire that causes real distress — a diagnosis called hypoactive sexual desire disorder (HSDD). It is a melanocortin receptor agonist that acts on signalling pathways in the brain involved in sexual desire, rather than on blood flow to the genitals. Bremelanotide has no EU marketing authorisation. It cannot legally be prescribed or dispensed by any doctor working in the EU, and Hi-Doctor does not offer it. An EU authorisation gap is not the same as a safety concern — it means the medicine has not been through the EU regulatory process. A GP or gynaecologist can look at hormones, mood, medication side effects and relationship factors together, which is the assessment low desire actually needs. Within Hi-Doctor's sexual health consultation, doctors review the case and consider EU-authorised options. See [low sexual desire](/library/conditions/low-libido) for how that consultation works. The RECONNECT phase 3 trials enrolled 1,267 women. Of those, 96.6% were recruited at US sites and 85.6% were white. The differences from placebo were small movements on questionnaire scales whose day-to-day meaning is debated. Nausea was reported by 40.0% of women given bremelanotide versus 1.3% on placebo; flushing by 20.3% versus 0.3%. It is an injection given under the skin of the stomach or thigh about 45 minutes before sex. PDE5 inhibitors such as [sildenafil](/library/medicines/viagra) treat erectile dysfunction, not HSDD. A doctor decides case by case whether any of them are relevant to what was reported in the questionnaire. ## How Hi-Doctor handles it One consultation, one doctor, one decision. A licensed doctor reviews every sexual health case; nothing is prescribed automatically. See [how it works](/essentials/how-it-works) and [pricing](/essentials/pricing) for the consultation process and cost of the medical review — medication, where something is prescribed, is paid separately at the pharmacy. ## Start a consultation Answer the sexual health questionnaire and a registered doctor reviews it. They decide whether treatment is appropriate, which one, and at what dose — and declining is a normal outcome. See [what it costs](/essentials/pricing) and [how the review works](/essentials/how-it-works). This page is reference information, not medical advice and not a prescription. Whether a medicine is appropriate for you is decided by a registered doctor after reviewing your consultation.