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Testosterone (patch)
The testosterone patch, brand name Intrinsa among others, was designed to treat female sexual dysfunction. Mechanism of action Testosterone patches works by releasing the hormone testosterone through the skin into the bloodstream. In women, testosterone is naturally produced by the ovaries and the adrenal gland. However, levels of the hormone decline with age, sometimes more after menopause. Testosterone therapy is systemic and needs to be applied over a period of weeks or months to have an effect.Can Intrinsa Be a Viagra for Women?
BusinessWeek, October 28, 2004. Retrieved June 22, 2007.
P&G licensed the treatment to Watson Pharmaceuticals.


Approval

The patch was granted a license from the

Female Sexual Dysfunction
Female sexual arousal disorder (FSAD) is a disorder characterized by a persistent or recurrent inability to attain sexual arousal or to maintain arousal until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity. The condition should be distinguished from a general loss of interest in sexual activity and from other sexual dysfunctions, such as the orgasmic disorder ( anorgasmia) and hypoactive sexual desire disorder, which is characterized as a lack or absence of sexual fantasies and desire for sexual activity for some period of time. Although female sexual dysfunction is currently a contested diagnostic, it has become more common in recent years to use testosterone-based drugs off-label to treat FSAD. Causes A number of studies have explored the factors that contribute to female sexual arousal disorder and female orgasmic disorder. These factors include both psych ...
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Off-label Use
Off-label use is the use of pharmaceutical drugs for an unapproved indication (medicine), indication or in an unapproved age group, dose (biochemistry), dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is very common and generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Pharmaceutical marketing, Marketing of pharmaceuticals for off-label use is usually prohibited. Indications and labeling laws An ''Indication (medicine), indication'' is when a drug is medically ap ...
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Androgens And Anabolic Steroids
An androgen (from Greek ''andr-'', the stem of the word meaning "man") is any natural or synthetic steroid hormone that regulates the development and maintenance of male characteristics in vertebrates by binding to androgen receptors. This includes the embryological development of the primary male sex organs, and the development of male secondary sex characteristics at puberty. Androgens are synthesized in the testes, the ovaries, and the adrenal glands. Androgens increase in both males and females during puberty. The major androgen in males is testosterone. Dihydrotestosterone (DHT) and androstenedione are of equal importance in male development. DHT ''in utero'' causes differentiation of the penis, scrotum and prostate. In adulthood, DHT contributes to balding, prostate growth, and sebaceous gland activity. Although androgens are commonly thought of only as male sex hormones, females also have them, but at lower levels: they function in libido and sexual arousal. Also, and ...
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Melanotan II
Melanotan II is a synthetic analogue of the peptide hormone α-melanocyte-stimulating hormone (α-MSH) that stimulates melanogenesis and increases sexual arousal. It was under development as drug candidate for female sexual dysfunction and erectile dysfunction but clinical development ceased by 2003, and as of 2018, no product containing melanotan II was marketed and all commercial development had ceased. Unlicensed, untested, or fraudulent products sold as "melanotan II" are found on the Internet, and purported to be effective as "tanning drugs", though side effects such as uneven pigmentation (it makes already uneven pigmentation more noticeable), new nevi (moles), and darkening or enlargement of existing moles have been reported and have led to medical authorities discouraging its use. There has been no scientific study into the long term and permanent side effects the use of this peptide may cause. Mechanism of action Melanotan II acts as a non-selective agonist of th ...
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Flibanserin
Flibanserin, sold under the brand name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD). The medication improves sexual desire, increases the number of satisfying sexual events, and decreases the distress associated with low sexual desire. The most common side effects are dizziness, sleepiness, nausea, difficulty falling asleep or staying asleep and dry mouth. Development by Boehringer Ingelheim was halted in October 2010, following a negative evaluation by the US Food and Drug Administration (FDA).Spiegel onlinePharmakonzern stoppt Lustpille für die Frau 8 October 2010 (in German) The rights to the drug were then transferred to Sprout Pharmaceuticals, which achieved approval of the drug by the US FDA in August 2015. Addyi is approved for medical use in the US for premenopausal women with HSDD and in Canada for premenopausal and postmenopausal women with HSDD. HSDD was recognized as a distinct sexual func ...
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Bremelanotide
Bremelanotide, sold under the brand name Vyleesi, is a medication used to treat low sexual desire in women. Specifically it is used for low sexual desire which occurs before menopause and is not due to medical problems, psychiatric problems, or problems within the relationship. It is given by an injection just under the skin of the thigh or abdomen. Common side effects include nausea, pain at the site of injection, and headache. It may also cause a temporary increase in blood pressure and decrease in heart rate after each dose, and darkening of the gums, face, and breasts. The medication is a peptide and acts by activating the melanocortin receptors. Bremelanotide was approved for medical use in the United States in 2019. It was developed by Palatin Technologies. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical uses Bremelanotide is used for the treatment of generalized hypoactive sexual desire disorder (HSDD) in premenopa ...
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List Of Androgens Available In The United States
This is a complete list of androgens/anabolic steroids (AAS) and formulations that are approved by the and available in the United States. AAS like testosterone are used in androgen replacement therapy (ART), a form of hormone replacement therapy (HRT), and for other indications. Testosterone and esters Testosterone (unmodified/non-esterified) is available in the following formulations: * Oral: Jatenzo (as testosterone undecanoate, a prodrug of testosterone) * Buccal tablets: Striant * Intranasal gels: Natesto * Transdermal: ** Gels: Androgel, Fortesta, Testim, Testosterone (generic) ** Solutions: Axiron, Testosterone (generic) ** Patches: Androderm, Testoderm (discontinued), Testoderm TTS (discontinued), Testosterone (generic) * Injectable oil solutions (as prodrugs of testosterone): ** Testosterone cypionate (Depo-Testosterone, Testosterone Cypionate (generic)) ** Testosterone enanthate (Delatestryl, Testosterone Enanthate (generic)) ** Testosterone undecanoate (Aveed) * Subcu ...
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Organon International
Organon & Co. is an American pharmaceutical company headquartered in Jersey City, New Jersey. Organon specializes in the following core therapeutic fields: reproductive medicine, contraception, psychiatry, hormone replacement therapy (HRT), and anesthesia. Organon sells to international markets. History Organon was founded by Dr. Saal van Zwanenberg in Oss, the Netherlands, in 1923 as a separate part of the meat factory Zwanenberg's fabrieken. Its first product was insulin in 1923. In the thirties it manufactured estrogens. In 1948, Organon acquired the Newhouse research site in Scotland, United Kingdom. The production of cortisone was initiated in 1953. In 1962, it bought the stock of the Nederlandsche Cocaïnefabriek. The company name was changed to Koninklijke Zwanenberg-Organon (KZO), and it merged with the fibre producer AKU in 1969 to become AKZO, later Akzo Nobel. Organon was the human health care business unit of Akzo Nobel. In 2004, Organon acquired active-pharmace ...
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Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying fro ...
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Testosterone (medication)
Testosterone (T) is a medication and naturally occurring testosterone, steroid hormone. It is used to treat male hypogonadism, gender dysphoria, and certain types of breast cancer. It may also be used to increase athletic ability in the form of doping in sport, doping. It is unclear if the use of testosterone for andropause, low levels due to aging is beneficial or harmful. Testosterone can be used as a gel or transdermal patch, patch that is applied to the skin, intramuscular injection, injection into a muscle, tablet that is Buccal administration, placed in the cheek, or tablet that is taken oral administration, by mouth. Common side effects of testosterone include acne, swelling (medical), swelling, and gynecomastia, breast enlargement in men. Serious side effects may include liver toxicity, heart disease, and behavioral changes. Women and children who are exposed may develop virilization, masculinization. It is recommended that individuals with prostate cancer not use the ...
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United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ...
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National Health Service
The National Health Service (NHS) is the umbrella term for the publicly funded healthcare systems of the United Kingdom (UK). Since 1948, they have been funded out of general taxation. There are three systems which are referred to using the "NHS" name ( NHS England, NHS Scotland and NHS Wales). Health and Social Care in Northern Ireland was created separately and is often locally referred to as "the NHS". The four systems were established in 1948 as part of major social reforms following the Second World War. The founding principles were that services should be comprehensive, universal and free at the point of delivery—a health service based on clinical need, not ability to pay. Each service provides a comprehensive range of health services, free at the point of use for people ordinarily resident in the United Kingdom apart from dental treatment and optical care. In England, NHS patients have to pay prescription charges; some, such as those aged over 60 and certain state ben ...
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