As men age, maintaining optimal sexual performance becomes increasingly challenging. Erectile dysfunction (ED) is estimated to affect around 20% of adult males over the age of 20, and by 2025, it is projected to impact 322 million men globally. PT-141 signifies a significant shift in the treatment of male sexual dysfunction. If you’re experiencing a decline in sexual performance as you age, PT-141 may provide the solution you’ve been searching for. At Tower Urology, we recognize that sexual health is a multifaceted aspect of overall well-being. The advantage of Tower Urology is our unwavering commitment to delivering world-class urologic care through advanced technology, personalized treatment plans, and a patient-centered approach.
Understanding PT-141
PT-141, also known as Bremelanotide, is a synthetic peptide utilized to treat sexual dysfunction in both men and women. Bremelanotide was approved for medical use in the United States in 2019 to treat hypoactive sexual desire disorder in premenopausal women. Many medications are often prescribed off-label for conditions that exceed their original FDA approval. Brand Name Description Bremelanotide injection is used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women who previously had no problems with sexual desire and that occurs in any type of stimulation, situation, or partner. It should only be used in women who have low sexual desire that is troubling to them and is not caused by a medical or mental health problem, problems in the relationship, or medicine or other drug use. Women who have gone through menopause and men should not use bremelanotide. Do not use this medicine to improve sexual performance. This medicine is available only with your doctor's prescription.
Interested in trying PT-141? Given the risks and drawbacks mentioned above, along with the absence of long-term safety data on PT 141, it is essential to consult your urologist before deciding to take it. Board-certified, fellowship-trained urologists staff Tower Men’s Health.
Mechanism of Action: A Brain-Centered Approach
PT-141, a synthetic hormone, works at the source of desire: the mind. This contrasts with traditional ED medications like Viagra and Cialis, which are PDE-5 inhibitors that increase blood flow to the penis.
PT-141 is a synthetic peptide that stimulates the brain’s melanocortin receptors and causes the brain to release nitric oxide. PT-141, a synthetic peptide analogue of alpha-MSH, is an agonist at melanocortin receptors including the MC3R and MC4R, which are expressed primarily in the central nervous system. Systemic administration of PT-141 to rats activates neurons in the hypothalamus as shown by an increase in c-Fos immunoreactivity. Neurons in the same region of the central nervous system take up pseudorabies virus injected into the corpus cavernosum of the rat penis. Discovery the many benefits offered by PT-141 injections, ranging from the remarkable enhancement of libido in both men and women to the profound improvement of orgasmic responses.
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- Dual Mechanism: PT 141 triggers nitric oxide release, which relaxes penile muscles and increases blood flow, helping men achieve an erection. This increase in blood flow can help men with ED achieve an erection. Because it also leads to increased desire rather than just increased blood flow to the sex organs, PT 141 also leads to improved sexual performance and has the potential for improved mood and general well-being.
Research and Studies
Administration of PT-141 to normal men and to patients with erectile dysfunction resulted in a rapid dose-dependent increase in erectile activity.
PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following intranasal administration in healthy male subjects and in Viagra-responsive erectile dysfunction (ED) patients. Erectile response was assessed by RigiScan trade mark in healthy subjects without visual sexual stimulation (VSS) and in Viagra-responsive ED patients with VSS. In healthy subjects, mean C(max) and AUC((0-t)) increased in a dose-dependent manner. Median T(max) was 0.50 h and mean t(1/2) ranged from 1.85 to 2.09 h. In both studies, an erectile response induced by PT-141 administration was statistically significant, compared to placebo, at doses greater than 7 mg, with the onset of the first erection occurring in approximately 30 min.
PT-141 was safely administered and well tolerated in both studies. A maximum-tolerated dose was not identified. Flushing and nausea were the most common adverse events reported in both studies and no clinically significant changes in vital signs, laboratory tests, ECGs, or physical exams were observed.
- Research suggests that PT-141 can work synergistically with traditional erectile dysfunction (ED) medications.
Administration and Dosage
It should be taken at least 45 minutes before planned sexual activity. A maximum of one dose is recommended per 24 hours, or no more than eight doses per month. PT 141 peptide therapy works by stimulating melanocortin receptors in the brain. It can be administered through injections or nasal inhalation and typically takes effect within an hour. Unlike other treatments that only increase blood flow, PT 141 boosts sexual desire, addressing the root cause of low libido. PT 141 works by stimulating melanocortin receptors in the brain. It can be injected under the skin or inhaled through the nose as a treatment for sexual dysfunction. It is known for taking effect quickly, usually in less than one hour.
- For injection dosage form (solution):
- Adults-1.75 milligrams (mg) injected under the skin at least 45 minutes before a sexual activity. Do not use more than one dose of this medicine within 24 hours. Do not use more than 8 doses per month.
- Children-Use is not recommended.
- Proper Use: A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach or thighs. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine. You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Check the liquid in the autoinjector pen. It should be clear or colorless. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Use a new needle each time you inject your medicine. You might not use all of the medicine in each autoinjector. Use each autoinjector only one time. Do not save an open autoinjector.
Precautions and Contraindications
Due to its effects on blood pressure-typically a transient increase of 6 mmHg in systolic blood pressure and 3 mmHg in diastolic blood pressure-bremelanotide is considered contraindicated for individuals with uncontrolled hypertension or cardiovascular disease.
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It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. If your condition does not improve within 8 weeks, or if it become worse, check with your doctor. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away. Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away. This medicine may cause darkening of the skin on the face, gums, or breasts, especially in patients with darker skin and daily use. Talk to your doctor if you have concerns about any skin changes. Nausea may occur after first using bremelanotide, which may last for 2 hours or more. Your doctor may give you an anti-emetic medicine for this. Check with your doctor right away if the nausea is severe or continuing. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Other Medical Problems: The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart or blood vessel disease or Hypertension (high blood pressure), uncontrolled-Should not be used in patients with these conditions.
- Kidney disease, severe or Liver disease, severe-Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
- Stomach or bowel problem (eg, slow gastric emptying)-Use with caution. May make this condition worse and decrease the absorption of oral medicines.
Drug Interactions: Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Naltrexone
Before Using: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
- Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
- Pediatric: Appropriate studies have not been performed on the relationship of age to the effects of bremelanotide injection in the pediatric population. Safety and efficacy have not been established.
- Geriatric: Appropriate studies have not been performed on the relationship of age to the effects of bremelanotide injection in the elderly. Safety and efficacy have not been established.
- Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Potential Side Effects
Like any other medication, PT 141 can cause side effects. Flushing is characterized by redness or a feeling of warmth or tingling in the skin. It occurs when the blood vessels in your skin become dilated. It is likely that you may experience mild to moderate itching, redness, or pain at the injection site after taking PT 141. The severity and duration of side effects can vary by individual. These include flushing, headaches, nausea, and skin irritation. Some individuals may experience blurred vision, darkening of the face or gums, dizziness, fatigue, joint pain, vomiting, and nasal congestion.
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- Side Effects: Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
- Check with your doctor immediately if any of the following side effects occur:
- Rare: Blurred vision dizziness headache nervousness pounding in the ears slow or fast heartbeat.
- Incidence not known: Dark urine general tiredness and weakness light-colored stools upper right abdominal pain yellow eyes and skin.
- Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- More common: Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site feeling of warmth redness of the face, neck, arms, and occasionally the upper chest.
- Less common: Aching or discomfort in the lower legs or sensation of crawling in the legs arm or leg pain burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings cough darkening of the face, gums, or breasts diarrhea difficulty in moving joint pain or swelling muscle pains, cramps, or stiffness runny or stuffy nose stomach pain.
- Rare: Chills fever general feeling of discomfort or illness loss of appetite shiverings sore throat sweating trouble sleeping
- Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
- Check with your doctor immediately if any of the following side effects occur:
Long-Term Safety and Potential for Misuse
The long-term safety of PT 141 is still under study. While a 52-week study showed effectiveness for women, long-term effects on the body, especially for those with other health conditions, are unknown. Like many medications, PT 141 could be misused if its effectiveness diminishes. The effects of PT 141 on hormone levels and fertility are not fully understood. The long-term effects of PT 141 have not yet been widely studied. This means that experts are uncertain about the safety of taking PT 141 over an extended period, especially for individuals with other health conditions. The potential for the abuse or misuse of a drug increases if its effectiveness decreases over time. With most drugs, the body develops a tolerance over time, so a higher dose is needed to achieve the same results.
Conclusion
PT-141 represents a novel approach to addressing sexual dysfunction in both men and women by targeting the central nervous system. It can be used to treat sexual desire disorder in women and erectile dysfunction in men by increasing sexual desire and blood flow to the sex organs. While studies have shown promising results, it is crucial to consider the potential risks and side effects. Due to the cons and risks outlined above, along with the lack of long-term safety data about PT 141, it is important that you discuss PT 141 with your doctor before deciding to take it. This is especially important if you have other health conditions like heart disease or high blood pressure.
- Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.