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Sexual Wellness

Sexual wellness: FDA-approved options

Start with the basics

Why it’s confusing

Let’s make sense of sexual wellness.

Too many opinions

Many voices, not much evidence-based guidance in one place.

Hype outruns the science

Claims tend to move faster than the research meant to support them.

Every site feels like an ad

Plain, honest information is surprisingly hard to find.

Where do you even start?

The basics are rarely explained in simple, everyday words.

It’s not you — the information out there is a mess. Here’s the clear version.

Start with the basics ↓

The research

Peptides studied for sexual wellness

One peptide is actually FDA-approved here.

Education, not medical advice. Talk to a doctor before starting anything. Different goal? Take the 60-second quiz →

Overview

What you need to know.

Sexual wellness treatment is a phrase many people search in private. Maybe low desire has crept into your life, and it worries you. You are not alone in wondering what to do.

It can be hard to know what is real and what is hype. You may wonder which options are safe, and which ones a doctor would recognize. The noise online makes that harder.

This page keeps things calm and simple. You will learn what sexual wellness covers, where an FDA-approved peptide option fits, and where to go next. Every fact here comes from FDA and trial sources.

Sexual Wellness

Getting started

Where to start with Sexual Wellness

1

Talk to Your Doctor

Rule out underlying health conditions. Performance issues can be a sign of cardiovascular, hormonal, or metabolic problems.

2

Choose a Provider

Compare telehealth providers based on privacy, pricing, format options, and trust signals. Read our provider comparison.

3

Complete Your Assessment

Online assessment takes 3-5 minutes. A licensed physician reviews your information and prescribes if appropriate.

Start here

PT-141: The FDA-Approved Peptide for Low Sexual Desire in Women

The FDA-approved peptide for low sexual desire (HSDD) in premenopausal women — how it works and what the research shows.

Start reading

KEY TAKEAWAYS

  • Sexual wellness covers desire, comfort, and connection, plus support from a licensed clinician.
  • Vyleesi® (bremelanotide) is FDA-approved for HSDD in premenopausal women, used as needed.
  • You inject Vyleesi® under the skin about 45 minutes before anticipated sexual activity.
  • Vyleesi® can briefly raise blood pressure after each dose, usually easing within 12 hours.
  • The RECONNECT phase 3 trials studied Vyleesi® in about 1,247 premenopausal women.

What readers want to figure out

  • You want to know what sexual wellness treatment really means.
  • You want to know which options are FDA-approved, not just hype.
  • You want clear facts on Vyleesi®, the FDA-approved peptide option.
  • You want to know who Vyleesi® is for, and who it is not.
  • You want to know where to go next for real help.

What sexual wellness means here

Sexual wellness is more than one thing. It covers desire, arousal, comfort, and feeling close to a partner. It also covers your confidence and your peace of mind.

Low desire that causes real distress is common. Research suggests it affects about 1 in 10 women aged 18 to 44 in the United States. So if this is you, you are far from alone.

Good sexual wellness care looks at the whole picture. That can include sleep, stress, your relationship, and your general health. A licensed clinician can help you sort out what is going on.

Medicine is only one part of that picture. This hub focuses on the FDA-approved peptide option that fits here. That option is Vyleesi®.

Where an FDA-approved peptide option fits

Among FDA-approved choices, one is a peptide. Its brand name is Vyleesi®, and the active ingredient is bremelanotide. The FDA approved it in 2019.

You may also see bremelanotide called PT-141. The FDA-approved product is Vyleesi®, so that is the name to anchor on. A full monograph lives at /peptides/pt-141/.

Sexual wellness is broad. The FDA-approved peptide option that fits here is Vyleesi® (bremelanotide).

Vyleesi® (bremelanotide): what it is

Vyleesi® is a melanocortin receptor agonist. That is a long name for a simple idea. It is a small peptide that acts on signals in the brain.

Bremelanotide is a lab-made copy of a natural body peptide. It attaches mainly to a target called the melanocortin-4 receptor. Scientists link that receptor to sexual desire.

The exact way Vyleesi® helps is not fully known. It is believed to work in brain areas tied to desire. That honest gap is normal for this kind of medicine.

What Vyleesi® is approved for

Vyleesi® is FDA-approved for one clear use. It is for premenopausal women with acquired, generalized HSDD. HSDD stands for hypoactive sexual desire disorder.

Acquired means the low desire is new for you. Generalized means it happens in most settings, not just one. The low desire must also cause you marked distress.

The label sets clear limits too. Vyleesi® is not for postmenopausal women, and it is not for men. It is also not meant to boost sexual performance.

There is a deeper guide to this condition. For a full look at HSDD, see the pillar at /conditions/hsdd/.

How Vyleesi® is taken

Vyleesi® comes as a shot you give yourself. The dose is 1.75 mg under the skin. You inject it into your belly or your thigh.

The timing is as-needed, not daily. You use it about 45 minutes before you expect sexual activity. It is made for the moment, not for every day.

There are simple limits to follow. You should not take more than one dose in 24 hours. You should not use more than eight doses in a month.

Give it a fair trial, but not forever. A prescriber may stop Vyleesi® after 8 weeks if it has not helped. That check keeps you from continuing something that is not working.

The blood pressure caution to know

Vyleesi® has one safety point that stands out. It can briefly raise your blood pressure after each dose. It can also lower your heart rate for a short time.

These changes are usually short-lived. They tend to settle within 12 hours of the dose. Still, they are the reason for careful screening.

Vyleesi® is not for everyone because of this. It should not be used with uncontrolled high blood pressure. It should not be used with known heart disease.

A clinician checks your heart health before you start. The most common side effects are nausea, flushing, and headache. Most are mild or moderate and ease with time.

Vyleesi® can briefly raise blood pressure, so it is not for people with uncontrolled hypertension or known heart disease.

What the RECONNECT trials found

The main evidence for Vyleesi® comes from RECONNECT. This was a pair of phase 3 trials, called Study 301 and Study 302. Both compared Vyleesi® to a placebo over 24 weeks.

About 1,247 premenopausal women took part across the two trials. All had acquired, generalized HSDD. They used the 1.75 mg shot as needed.

Women on Vyleesi® saw a real rise in sexual desire. On the desire score, the combined gain over placebo was 0.35 (P<0.001). That result was statistically significant.

Women on Vyleesi® also felt less distress about low desire. On the distress score, the combined result was a drop of 0.33 versus placebo (P<0.001). These numbers apply to the FDA-approved product.

Who Vyleesi® may suit, and who it is not for

Vyleesi® may suit a specific reader. She is premenopausal, has HSDD, and feels real distress about it. Her blood pressure is well controlled, and her heart is healthy.

Vyleesi® is not for some groups. It is not for postmenopausal women or for men. It is not for anyone with uncontrolled high blood pressure or known heart disease.

This is a quick, hub-level view. For a deeper fit check and the full HSDD picture, the condition pillar at /conditions/hsdd/ goes further.

Vyleesi® at a glance

Here is Vyleesi® in one view. The table sums up its approved use, how it is taken, and its key caution.

FDA-approved option Approved use How it is taken Key caution
Vyleesi® (bremelanotide) HSDD in premenopausal women (acquired, generalized) Subcutaneous shot, as needed, about 45 minutes before activity Short-term blood pressure rise; not for uncontrolled hypertension or known heart disease

Where to go next

You have the overview, so here are your next steps. Each one is a page that goes deeper on a piece of this puzzle.

To learn the drug in full, read the Vyleesi® (bremelanotide) monograph at /peptides/pt-141/. It covers how it works, the trial results, and safety in more detail.

To understand the condition, see the HSDD pillar at /conditions/hsdd/. It explains causes, diagnosis, and the questions to bring to a clinician.

To learn where to get it, see the Vyleesi® provider comparison at /compare/vyleesi-providers/. It weighs licensed clinicians on how they operate, not on hype.

The Bottom line

Sexual wellness is broad, and help is real. Among FDA-approved choices, the peptide option is Vyleesi® (bremelanotide). It is for premenopausal women with acquired, generalized HSDD.

Keep the key facts in mind. Vyleesi® is a shot used as needed, and it can briefly raise blood pressure. Its evidence comes from the RECONNECT trials in about 1,247 women.

Your next step is simple. Read the Vyleesi® monograph, explore the HSDD pillar, or compare where to get it. A licensed clinician can guide the choice with you.

Sources

  1. VYLEESI® (bremelanotide injection) Prescribing Information. US Food and Drug Administration. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf
  2. Kingsberg SA, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials (RECONNECT). Obstet Gynecol. 2019;134(5):899-908. https://pmc.ncbi.nlm.nih.gov/articles/PMC6819021/
  3. US Food and Drug Administration. Vyleesi® Approval Package (NDA 210557). 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000Approv.pdf
  4. Simon JA, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder (open-label extension). 2019. https://pmc.ncbi.nlm.nih.gov/articles/PMC6819023/
  5. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bremelanotide. NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK573221/
  6. Clayton AH, et al. Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. 2022. https://pubmed.ncbi.nlm.nih.gov/35230162/

Last updated: 2026-07-10 · Editorially reviewed by the Peptides.io team

KEEP READING

Vyleesi® (bremelanotide): the full monograph

You have the overview. Next, get the deep facts on Vyleesi® (bremelanotide): how it works, the RECONNECT results, dosing, and safety.

Read next: /peptides/pt-141/

Good to know

Quick tips

1

Talk to your doctor first. Performance issues can be a sign of underlying health conditions like cardiovascular disease or hormonal imbalances.

2

PDE5 inhibitors (sildenafil, tadalafil) work for about 80% of people. They are FDA-approved and well-studied.

3

Telehealth makes the process private — online assessment, physician review, discreet delivery. No waiting rooms.

4

Exercise improves blood flow, confidence, and hormonal health. It is one of the best interventions for sexual wellness.

5

Alcohol and smoking both significantly impair sexual performance. Reducing either can make a noticeable difference.

6

If desire is the issue (not function), PT-141 works through a different mechanism — talk to your doctor.

Sexual Wellness

Guide Library

Guides to help you make informed decisions.

FAQ

Common questions

What does sexual wellness treatment mean?
Sexual wellness treatment is a broad idea, not a single product. It covers desire, arousal, comfort, and feeling close to a partner. Care can include lifestyle steps, support for your relationship, and help from a licensed clinician. When medicine fits, one FDA-approved peptide option is Vyleesi® (bremelanotide) for premenopausal women with HSDD.
What is Vyleesi® (bremelanotide)?
Vyleesi® is the brand name, and bremelanotide is the active ingredient. It is a small peptide known as a melanocortin receptor agonist. It attaches mainly to the melanocortin-4 receptor, which scientists link to sexual desire. The FDA approved Vyleesi® in 2019 for premenopausal women with acquired, generalized HSDD. You may also see bremelanotide called PT-141.
Who is Vyleesi® FDA-approved for?
Vyleesi® is FDA-approved for premenopausal women with acquired, generalized HSDD. Acquired means the low desire is new for that person. Generalized means it happens in most settings. The low desire must also cause marked distress. The label states that Vyleesi® is not for postmenopausal women, not for men, and not for boosting sexual performance.
How do you take Vyleesi®?
You give yourself Vyleesi® as a 1.75 mg shot under the skin. You inject it into your belly or thigh, about 45 minutes before anticipated sexual activity. It is used as needed, not daily. You should not take more than one dose in 24 hours, or more than eight doses in a month.
What is the blood pressure caution with Vyleesi®?
Vyleesi® can briefly raise your blood pressure and lower your heart rate after each dose. These changes usually settle within 12 hours. Because of this, Vyleesi® should not be used by anyone with uncontrolled high blood pressure or known heart disease. A clinician checks your heart health before and during use.

When you are ready to decide

See the top sexual wellness brands, compared

Once you understand your options, here are the products and providers we have vetted — scored side by side, so you can decide with a clear head. Always talk to a licensed provider first.