LibiGel, Hormone Gel to Increase Female Libido?
LibiGel is a revolutionary step forward in improving female sexual health. A testosterone gel that is to be applied daily to the upper area of a women’s arm with the goals of treating Hypoactive Sexual Desire Disorder (HSDD) and Female Sexual Dysfunction (FSD). This method allows testosterone, a hormone, to be absorbed through the skin, delivering the hormone into the bloodstream effortlessly and painlessly. The LibiGel solution has an advantage over other transdermal systems like a testosterone patch or cream.
Need for LibiGel in Women within the United States
The idea for LibiGel is to become the first FDA approved product on the market to successfully treat female sexual dysfunction and women suffering low libido. Currently, there are no products cleared by the FDA available to women in the US and there is an overwhelming need for this type of treatment according to US health advisors. It is estimated that 35%-45% of women suffer symptoms of low female libido and the race has been on for years to search for a working Viagra for women. The development program supporting LibiGel is confident they can improve sexual desire in women resulting in increased frequency of pleasurable sexual events while decreasing the anxiety and stress associated with women looking to boost their libido.
Development Status & Availability
Currently in Phase III trials under a Special Protocol Assessment agreement that was made official on January 24th, 2008. The good news is that LibiGel's Phase II regulatory trials were extremely successful for BioSante. In completion of the study a few things were confirmed.
- Confirmation from the FDA that HSDD and FDS are valid conditions realized by women
- LibiGel proved to significantly increase the amount of sexual activity by over 230% versus placebo
- No subject had serious adverse events or discontinued use due to events occurred during trials
- The entire study was double-blind and controlled by a placebo done in the US with surgically menopausal women with symptoms of low sexual desire and minimal sexual activity
As with any FDA trial many things need to be examined and proven. LibiGel has held its weight in the effectiveness department and so far there has not been a safety issue. In order to ensure safety regulations are met BioSante is putting LibiGel through an additional randomized trial on cardiovascular events with over 2500 women for 12 months. In addition BioSante plans to monitor over 300 women for an additional 6 months. This is a very serious testing period and will determine if LibiGel can be released to the public within the next year or two. After this trial is conducted BioSante will submit a LibGel NDA for review and potential approval by the FDA.
Market Viability
In a recent research survey run by the firm including gynecologists and general practitioners the need is overwhelming. Over 80 percent of those surveyed stated there is either a need or a great need for a valid treatment for HSDD or FDS in the US. Some physicians are currently prescribing some form of testosterone cream or patch treatment to women to assist with low female libido and only after a product like LibiGel becomes available will there be an FDA approved therapy for this serious disorder. There have been over 2 million prescriptions of the above therapies according to IMS Health and they are being prescribed “off label” currently. The vice president of clinical development, Michael Snabes made a press release in February containing details on the development of the new drug and it’s viability. Also, the CEO of BioSante has made comments that they are confident there is a very large market for a FSD treatment in short order.
LibiGel Alternatives on the Market Today
Currently, women have either been seeing there doctor and being prescribed these off label testosterone treatments or looking to the homeopathic solution industry for female libido enhancement. There are a plethora of organic and natural libido boosters being very heavily marketed on the internet including:
- Lyriana
- Provestra
- Vigorelle
- Orexia
- and many others
Containing ingredients like Suma Root, Wild Yam, Macca, Motherwort, Horney Goat Weed, Ginkgo, and other natural ingredients thought to be female aphrodisiac these products are not FDA approved and usually come in the form of creams, ointments, and tablets or pills to aid in vaginal lubrication, increase of female stimulation, or general vascular health. LibiGel will surely put a wrinkle in their market if and when it is released to the public. I personally know a lot of women who have been waiting a very long time for a serious treatment to be prescribed by their doctor. I for one am one of those women. Since my hystorectomy I have suffered a decreased libido and my marriage has suffered as a result. I have tried many formulas, counseling, and therapy but nothing has really been able to put the spark back into my sexual life. Hopefully this product gets approved and released to market sooner than later.
LibiGel News:
- Written by:
- Elizabeth Spirely
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