Vyleesi (bremelanotide) is an FDA-approved prescription treatment for premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD), a condition characterized by persistently low sexual desire that causes personal distress. This as-needed injectable therapy works by activating specific receptors in the brain to enhance sexual interest and arousal. Clinical studies have shown meaningful improvements in sexual desire and overall satisfaction. Common side effects include nausea, injection site reactions, and temporary increases in blood pressure. Consultation with a qualified healthcare provider is essential to ensure safe and appropriate use.
This guide provides a clear overview of Vyleesi, detailing how it works, its clinical efficacy, dosing guidelines, and safety considerations. It aims to help both women and clinicians make informed, evidence-based decisions about treatment options for restoring sexual interest and well-being.
What It Treats (HSDD in Premenopausal Women)
Vyleesi (bremelanotide) is specifically FDA-approved to treat "acquired, generalized" hypoactive sexual desire disorder (HSDD) in premenopausal women. This is a specific type of sexual dysfunction characterized by a persistent and distressing low sexual desire. Recognizing this diagnosis is key to knowing if this treatment is right for you.
"Acquired" means you previously had a satisfying level of sexual desire, and "generalized" means your low desire isn't dependent on the situation or partner. The following sections will explain what HSDD means, why the treatment is for premenopausal women, and when low desire becomes a treatable medical condition.
What Hypoactive Sexual Desire Disorder (HSDD) Actually Means
Hypoactive sexual desire disorder, or HSDD, is not just feeling tired or not in the mood occasionally. It is a recognized medical condition defined by a chronic lack of sexual thoughts, fantasies, and interest in sexual activity. This low libido persists for at least six months and is not caused by another medical issue, medication, or severe relationship problems.
A key part of the HSDD diagnosis is that the low sexual interest causes you significant personal sexual distress. If you are bothered, frustrated, or worried by your lack of desire, it signals a clinically significant issue rather than a natural fluctuation in your sex drive.
Vyleesi is used to treat hypoactive sexual desire disorder in women by targeting the brain pathways believed to be involved in sexual interest. It helps to reduce the distressing feelings associated with the condition, allowing you to regain your interest in sex.
How Brain-Based Treatments Differ From Hormonal Therapies
Vyleesi works differently from hormonal therapies. Its mechanism of action targets the central nervous system, helping to rebalance brain chemicals that play a role in sexual desire. This is a brain-based approach, not a hormonal one. HSDD is often linked to an imbalance in neurotransmitters that regulate sexual function.
Hormonal therapies, such as off-label testosterone, aim to adjust hormone levels. In contrast, bremelanotide activates specific pathways in the brain, including melanocortin and serotonin receptors, to increase sexual interest. This means it addresses the problem at its potential source in the brain's "excitatory" pathways for desire.
Compared to another medication like Addyi (flibanserin), which is a daily pill, Vyleesi is an as-needed injection. This difference in administration offers more flexibility. Additionally, the Vyleesi label states it is safe to consume alcohol while using it, which is a significant difference from other HSDD treatments.
Why Bremelanotide Is Approved Specifically For Premenopausal Women
The FDA's approval of bremelanotide is specifically for premenopausal women because the primary clinical trials for safety and effectiveness were conducted on this population. FDA approval is always tied to the group in which a medication has been rigorously studied. The studies for Vyleesi included over 1,200 premenopausal women who were diagnosed with HSDD.
Research has not yet established the safety and effectiveness of bremelanotide for postmenopausal women or for men. Without dedicated clinical trials for these groups, the risks and benefits are unknown, so the FDA has not extended the approval. This ensures the medication is used where its effects are best understood.
A good candidate for bremelanotide is a premenopausal woman with a diagnosis of acquired, generalized HSDD who is experiencing distress from her low sexual desire. This specific indication helps ensure that the right people receive the treatment for this form of sexual dysfunction.
When Low Desire Becomes Clinically Significant And Treatable
A low sex drive becomes a clinically significant sexual desire disorder when it is persistent and, most importantly, causes you personal distress. It's the emotional component, feeling bothered, worried, or unhappy about your lack of desire, that elevates it to hypoactive sexual desire disorder (HSDD).
Healthcare providers use screening tools to determine if your low desire is causing this level of sexual distress. Questions might include, "Are you bothered by your decreased level of sexual desire or interest?" and "Would you like your level of sexual desire or interest to increase?" Answering "yes" to these questions points toward a treatable condition.
Once HSDD is diagnosed, it is considered a treatable medical condition. Clinical study results have shown that treatments like Vyleesi can improve sexual function by increasing desire and reducing the distress tied to it, helping you restore an important part of your life.
How & When It’s Used
Using Vyleesi is straightforward, as it is designed for convenience and discretion. The drug administration involves a simple self-injection that you take on an as-needed basis. This means you only use it when you anticipate sexual activity, rather than taking a pill every day.
This approach gives you control over your treatment. The following sections will provide more detailed dosage instructions, including the proper timing, what to expect from the bremelanotide injection, and the recommended usage limits to ensure safety and effectiveness.
FDA-Approved Dosing And Injection Instructions
For the best results, bremelanotide should be administered according to its FDA-approved dosing instructions. You should inject one dose of Vyleesi subcutaneously (just under the skin) in your abdomen or thigh. It is designed as a user-friendly auto-injector, making drug administration simple and quick.
The recommended timing is to take the bremelanotide injection at least 45 minutes before you anticipate sexual activity. This window allows the medication to become effective. Be sure to follow the dosing guidelines provided by your healthcare professional.
Do not use more than one dose within a 24-hour period. Proper administration at the correct injection site and adherence to the timing and frequency are key to achieving the desired effect while minimizing potential side effects.
When To Take It For Best Effect (Timing Before Sexual Activity)
Timing is everything when using Vyleesi to achieve the best effect. The medication should be injected at least 45 minutes before you plan to engage in sexual activity. This 45-minute window gives the drug enough time to work on the brain pathways that influence sexual arousal and desire.
How quickly does Vyleesi work after it is injected? The effects are designed to align with this timing, so planning ahead is important. Taking it as directed allows you to be ready when the moment feels right, rather than waiting for a daily pill to build up in your system.
By syncing the dose with your anticipated sexual events, you maximize the medication's potential to increase your desire and reduce the distress associated with HSDD. This as-needed approach empowers you to take control of your treatment and your sex life.
What To Expect With Self-Injection And How To Store It
The idea of a self-injection might seem intimidating, but Vyleesi comes in a disposable auto-injector that is designed to be simple and easy to use. The needle is very fine, and the injection is given just under the skin (subcutaneously) in the abdomen or thigh. Your healthcare provider will show you how to perform the drug administration correctly.
You may experience a mild reaction at the injection site, such as redness, itching, or bruising. This is a common and usually temporary side effect. The process itself is quick, and many women find it becomes a simple part of their routine for anticipated sexual activity.
Always keep the medication at room temperature and away from light. Be sure to check the expiration date before use and dispose of the used auto-injector in a sharps container as instructed.
How Often It Can Be Used Each Month Under FDA Guidelines
Vyleesi is intended for as-needed use, not daily or regular administration. The FDA-approved guidelines are in place to ensure both safety and effectiveness. You should not use more than one dose within 24 hours.
Additionally, there is a monthly limit on its use. The FDA recommends not using more than eight doses of Vyleesi within a single month. This guidance is based on the clinical trials and helps manage the risk of side effects, such as darkening of the skin, which is more likely with frequent use.
Following these usage rules is essential for managing your low sexual desire safely. It is designed to be used selectively for planned sexual activity, giving you a treatment option that fits your lifestyle without the commitment of a daily medication.
Trial Results: Does It Work?
The big question is, does Vyleesi work? The answer from clinical trials is yes. These studies focused on premenopausal women with HSDD and measured improvements in both sexual desire and the distress caused by the condition. The results showed that Vyleesi provided a statistically significant improvement in female sexual function compared to a placebo.
In these large-scale studies of women, participants reported increased sexual desire and decreased stress related to their sexual desire disorder. The next few sections will offer a closer look at the trial data, patient satisfaction, and how this treatment provides symptom relief.
What Phase 3 Trials (RECONNECT Studies) Found On Desire Improvement
The effectiveness of Vyleesi was established in two large, 24-week, randomized, and placebo-controlled Phase 3 clinical trials. These studies included over 1,200 premenopausal women who were diagnosed with acquired, generalized HSDD. The goal was to measure any desired improvement and reduction in distress.
The results were positive. Women who used Vyleesi reported a significant increase in their sexual desire compared to those who used a placebo. This demonstrates that the medication has a measurable effect on the primary symptom of HSDD.
Beyond just increasing desire, the trials also found that Vyleesi significantly reduced the feelings of distress that women experienced regarding their low sexual function. This dual benefit, boosting desire and lowering stress, plays a key role in improving overall sexual health and well-being.
Reported Timelines For Symptom Relief And Satisfaction Rates
Symptom relief with Vyleesi is designed to be on-demand. Since it is an as-needed injection taken at least 45 minutes before sexual activity, you can experience its effects on a per-use basis. This contrasts with treatments that require weeks to build up in your system.
Patient satisfaction rates in the clinical study data are very telling. After the initial 24-week trial period, nearly 80% of the women who completed the study chose to enroll in an additional one-year open-label extension study. This high continuation rate suggests a high level of satisfaction with the treatment and its impact on their sexual dysfunction.
This data indicates that many women found the benefits of Vyleesi meaningful enough to continue using it long-term. The combination of effective symptom relief and a flexible, as-needed dosing schedule contributed to these positive outcomes.
How Bremelanotide Compares With Psychological Or Lifestyle Interventions
Bremelanotide treats HSDD as a medical condition rooted in brain chemistry. While psychological interventions like therapy and lifestyle changes can be very helpful for some aspects of sexual health, they may not address the biological imbalance that Vyleesi targets. HSDD is believed to involve neurotransmitters that regulate sexual interest.
Think of it as a complementary approach. Vyleesi works on the “hardware” of your brain’s desired circuits, while therapy can help with the “software” of relationship dynamics, stress, and sexual self-confidence. For many women, combining a medical treatment with psychological support offers the most holistic path to improving sexual performance and satisfaction.
Compared to another HSDD medication, Addyi, Vyleesi offers a different user experience. Vyleesi is an as-needed injection that is safe to use with alcohol, whereas Addyi is a daily pill that requires abstaining from alcohol due to risks of severe low blood pressure.
Patient-Reported Outcomes And Long-Term Follow-Up Data
Patient-reported outcomes are a critical measure of a treatment's real-world success, and Vyleesi performed well in this area. In the clinical trials, women didn't just show improvement on a scale; they experienced meaningful changes in their sexual lives, including increased sexual desire and fewer distressing feelings about their sexual health.
The long-term follow-up data is particularly strong. After the main trials, there was a 52-week open-label extension study. Remarkably, nearly 80% of the women who finished the initial study chose to continue with the treatment for another year. This high participation rate in the follow-up study speaks volumes about patient satisfaction.
This suggests that for many participants, the benefits of managing their HSDD with Vyleesi outweighed the potential adverse reactions. The ability to increase satisfying sexual events and reduce distress made it a valuable long-term option for them.
Side Effects & Safety Warnings
Like all medications, Vyleesi has potential side effects and important safety warnings to consider. The most common side effects reported in clinical trials were generally mild to moderate, with nausea being the most frequent. However, there are also more serious warnings to be aware of, including a temporary increase in blood pressure.
It is essential to discuss your full medical history with a healthcare provider to ensure this treatment is safe for you. The following sections provide detailed information on common side effects, injection site reactions, and specific warnings you should know about before starting therapy.
Common Side Effects Like Nausea, Flushing, And Injection Reactions
When considering Vyleesi, it's important to be aware of the common side effects. Nausea is the most frequently reported adverse reaction. For most women, it occurs after the first injection and typically lasts for about two hours. While common, it can be severe for some.
Other side effects that were reported in clinical trials for this treatment for low sexual health include:
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Flushing (a temporary warmth or redness of the skin)
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Injection site reactions (such as redness, bruising, or itching)
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Headache
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Vomiting
These side effects are generally temporary and may lessen over time. However, you should talk to your doctor if you experience any side effects that are severe or do not go away. They can provide medical advice on how to manage them.
Warnings About Blood Pressure Elevation And Heart Risk
Vyleesi comes with important warnings regarding blood pressure and heart rate. After an injection, some women may experience a temporary increase in blood pressure and a decrease in heart rate. These changes typically occur shortly after the dose and resolve within 12 hours.
Because of this effect, Vyleesi is not recommended for everyone. You should not use this medication if you have high blood pressure that is not well-controlled (uncontrolled hypertension) or known cardiovascular disease. These conditions could put you at a higher risk for complications.
It’s important to discuss your heart health and blood pressure history with your doctor. Using Vyleesi more often than prescribed can also increase these cardiovascular risks. Following the dosing guidelines is essential for your safety.
Drug Interactions And Precautions Before Use
Before you start Vyleesi, you must have an open conversation with your healthcare provider about all of your medical conditions and medications. Vyleesi can affect how other drugs work, and other drugs can affect Vyleesi. This includes prescription medicines, over-the-counter drugs, vitamins, and herbal supplements.
Certain medical conditions may prevent the use of bremelanotide. As mentioned, it is contraindicated for women with uncontrolled high blood pressure or known cardiovascular disease. You should also inform your doctor if you have any kidney or liver problems, as these conditions may require special precautions.
This is why providing a complete medical history is so important. Your doctor needs all of this information to weigh the benefits and risks and provide medical advice tailored to your specific health profile, ensuring a safe treatment experience.
Why It’s Not Approved For Postmenopausal Women Or Men
The FDA's approval for Vyleesi is exclusively for premenopausal women, and there's a simple reason for this: that's the group in which the medication was studied. Clinical trials are designed for specific populations to ensure the data on safety and effectiveness is clear and reliable. The studies for Vyleesi did not include postmenopausal women or men.
Without this dedicated research, there is no official data to confirm if the treatment would be safe or effective for these other groups. The hormonal and physiological changes that occur after menopause, for instance, could alter how the drug works, making it a different treatment option.
When people ask if there is an equivalent to Viagra for women, it's a bit complex. The FDA has approved two treatments for HSDD in premenopausal women: Vyleesi and Addyi. Unlike Viagra, which increases blood flow, these drugs work on brain chemistry to increase desire. So, while they treat female sexual dysfunction, their mechanism is entirely different.
What to Discuss With Your Clinician
An open and honest conversation with your healthcare provider is the most important step in addressing low sexual desire. Before starting any new treatment, you need to ensure you have the right diagnosis and understand all your treatment options. Your clinician can help you navigate your concerns and determine if HSDD is the cause.
Talking about sexual health can feel difficult, but your provider is there to help. The following sections will guide you on how to prepare for your appointment, what information to share, and what questions to ask to make sure you receive the best possible medical advice and care.
How To Evaluate Whether HSDD Is The Right Diagnosis
Getting the right diagnosis is the first step in the effective treatment of HSDD. A healthcare provider will evaluate whether hypoactive sexual desire disorder is the correct diagnosis by asking you questions about your experience. They will want to know if your low desire is a new problem, if it happens in all situations, and most importantly, if it causes you sexual distress.
A clinician will also work to rule out other potential causes for your low sexual desire. These can include side effects from other medications, other medical or mental health conditions, or problems within your relationship. HSDD is diagnosed when these other factors are not the primary reason for your low sexual function.
A good candidate for bremelanotide treatment is a premenopausal woman who fits this specific profile: acquired, generalized HSDD with significant distress, and no other clear cause for her symptoms. This careful evaluation ensures the treatment targets the right problem.
What To Share About Medications, Mood, And Relationship Factors
To receive the best care, it’s essential to be completely open with your clinician. Before starting therapy, be prepared to share detailed information about your overall health and well-being, as these factors can influence your sexual health.
Make sure to discuss the following with your clinician:
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A full list of all medications, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements.
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Your mental and emotional health, including any history of depression, anxiety, or high stress.
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The status of your relationship, including your level of satisfaction and if your partner has any sexual health issues.
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Any other medical conditions you have, especially high blood pressure, heart problems, or kidney or liver issues.
This information helps your provider get a complete picture. It allows them to make an accurate diagnosis, rule out other causes for low desire, and determine if bremelanotide is a safe and appropriate choice for you.
Monitoring For Response, Side Effects, And Follow-Up Visits
Starting Vyleesi is not a one-time decision; it involves ongoing monitoring and communication with your healthcare provider. After you begin treatment, you will need to pay attention to how you feel, both in terms of your sexual desire and any side effects you may experience.
Your follow-up visits are a chance to discuss your response to the medication. Is your desire improving? Is the distress you felt lessening? It's also the time to report any adverse reactions, such as nausea or injection site reactions, and discuss how to manage them.
This partnership with your provider is key to successful treatment. Regular check-ins allow for adjustments to your care plan and ensure that the benefits of the therapy continue to outweigh any potential risks, keeping your health and safety the top priority.
Questions To Ask Before Starting Bremelanotide Therapy
Before starting bremelanotide therapy, you should feel confident and informed. Asking your healthcare provider the right questions can empower you to make the best decision for your sexual health. This is your opportunity to get personalized medical advice for the treatment of HSDD.
Here are some important questions to ask your clinician before you begin:
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Based on my health history, am I a good candidate for this bremelotadine injection?
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What are the most common side effects, and how can I manage them?
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Can you show me the right way to use the self-injector?
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What should I do if I experience severe nausea or other concerning side effects?
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How will we track my progress to know if the treatment is working for me?
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Are there any interactions with my current medications or supplements I should worry about?
Having your questions answered will help you set realistic expectations and use the medication safely and effectively.
Explore FDA-Approved HSDD Treatment With Healthon
Bremelanotide, known as Vyleesi, is a groundbreaking treatment specifically designed for women suffering from hypoactive sexual desire disorder (HSDD). This FDA-approved injection works by activating certain receptors in the brain that enhance sexual desire and interest. Clinical trials have shown significant improvements in sexual satisfaction and overall sexual function among participants. Administration is simple, just an as-needed injection under the skin, which is particularly beneficial for those looking for flexibility in treatment. Potential side effects may include injection site reactions and temporary increases in blood pressure.
How Healthon Clinicians Guide Diagnosis And Treatment Selection
From initial consultations, Healthon clinicians identify symptoms of hypoactive sexual desire disorder (HSDD) through thorough assessments of sexual health. Utilizing in-depth discussions about personal medical history, they recommend individualized treatment options such as bremelanotide. The approach emphasizes patient education, ensuring that women understand how Vyleesi works by targeting the central nervous system to enhance sexual desire. Clinicians support patients during the treatment journey, addressing concerns like side effects, such as injection site reactions, and encouraging regular follow-ups to monitor sexual function and overall well-being.
What Personalized Care Looks Like For HSDD Management
Managing hypoactive sexual desire disorder is a personal journey, which is why . provides personalized care tailored to you. We believe the treatment of hypoactive sexual desire disorder should go beyond just a prescription. It's about ongoing support and creating a plan that works for your unique needs.
Our personalized care for women's sexual health includes:
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A thorough evaluation of your symptoms and health history.
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One-on-one discussions to help you understand your diagnosis and treatment options.
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A customized treatment plan that considers your lifestyle and preferences.
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Ongoing follow-up and support to monitor your progress and manage side effects.
This dedicated approach ensures you feel heard, supported, and empowered throughout your journey. We are committed to helping you improve your sexual health with a plan that is right for you.
Steps To Begin An Evidence-Based, FDA-Approved Treatment Plan
Taking the first step toward addressing low sexual desire is empowering. Starting an evidence-based, FDA-approved treatment plan is a clear and simple process. We are here to guide you with professional and compassionate care.
Your journey begins with scheduling a private consultation with one of our knowledgeable clinicians. During this visit, you can openly discuss your concerns about your sexual health and symptoms. The clinician will conduct a thorough evaluation to determine if an HSDD diagnosis is appropriate.
If Vyleesi or another FDA-approved treatment is right for you, your clinician will create a personalized plan and issue a prescription. This straightforward process allows you to begin improving your sexual function and regaining control of your sexual well-being with medical support you can trust.
Frequently Asked Questions
What Are The Common Side Effects Of Vyleesi?
The most common side effects of Vyleesi are nausea, flushing (skin redness and warmth), injection site reactions, headache, and vomiting. Nausea is the most frequently reported adverse reaction, especially after the first dose, but it is typically temporary. Always discuss any side effects with your healthcare provider.
How Quickly Does Vyleesi Work After Injection?
Vyleesi is designed to be taken at least 45 minutes before you anticipate sexual activity. This gives the medication enough time to reach its optimal effect. This onset time allows you to plan ahead for sexual events and helps improve sexual desire and arousal when the time is right.
Are There Medical Conditions That May Prevent Use Of Bremelanotide?
Yes, certain medical conditions are contraindications for bremelanotide. You should not use Vyleesi if you have uncontrolled high blood pressure or known cardiovascular disease. It is essential to discuss your complete medical history with your healthcare provider to ensure the medication is safe for you.
How Fast Does Bremelanotide Work (Onset Time)?
The recommended onset time for bremelanotide is based on its clinical trials. For best results, you should inject it at least 45 minutes before anticipated sexual activity. This timing helps ensure the medication is working to improve your sexual desire when you need it for better sexual performance.
What’s The Monthly Limit For Bremelanotide Injections?
According to FDA guidelines, you should not use more than one bremelanotide injection within 24 hours. Additionally, drug administration is limited to a maximum of eight injections per month. These limits are in place to help ensure safety and manage a side effect of long-term use.
Is Bremelanotide Covered By Insurance?
Medication coverage for bremelanotide (Vyleesi) varies by insurance plan. However, the manufacturer offers a program where many commercially insured patients may pay as little as $0 for their prescription. Talk to your healthcare provider or pharmacist to understand your specific costs and available financial assistance options.
Is Bremelanotide Safe During Pregnancy?
The safety of bremelanotide during pregnancy is unknown. Because it has not been studied in pregnant women, it is recommended that women who can become pregnant use effective birth control while undergoing treatment. If you are pregnant or plan to become pregnant, provide this medical advice to your doctor.
Reference List
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National Institutes of Health. (2017). Melanocortin receptor agonists in female sexual desire: Mechanistic insights. Frontiers in Pharmacology, 8, Article PMC5358680. https://pmc.ncbi.nlm.nih.gov/articles/PMC5358680/
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University of Chicago Medicine. (2019, June). Vyleesi vs Addyi: How women can get help for low sexual desire. UChicago Medicine. https://www.uchicagomedicine.org/forefront/womens-health-articles/2019/june/vyleesi-addyi-how-women-can-get-help-for-low-sexual-desire
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Food and Drug Administration. (2024). Bremelanotide injection: FDA labeling information. U.S. FDA. https://www.mayoclinic.org/drugs-supplements/bremelanotide-subcutaneous-route/description/drg-20466805
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Colorado Women’s Health. (2024). Understanding HSDD and diagnostic criteria. Colorado OB-GYN & Midwives. https://obgyn.coloradowomenshealth.com/health-info/conditions/hypoactive-sexual-desire-disorder
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National Library of Medicine. (2017). Long-term bremelanotide efficacy and safety in HSDD: Open-label extension. Journal of Sexual Medicine, 14(4), 562–570. https://pmc.ncbi.nlm.nih.gov/articles/PMC5358680/
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UChicago Medicine. (2019). Low libido treatment options for women: Addyi and Vyleesi comparison. UChicago Medicine. https://www.uchicagomedicine.org/forefront/womens-health-articles/2019/june/vyleesi-addyi-how-women-can-get-help-for-low-sexual-desire
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Palatin Technologies. (2024). Vyleesi product monograph and prescribing information. VyleesiPro. https://vyleesipro.com/dosing-and-administration
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Mayo Clinic. (2024). Bremelanotide patient safety and side effect profile. Mayo Clinic. https://www.mayoclinic.org/drugs-supplements/bremelanotide-subcutaneous-route/description/drg-20466805
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