LibiGel Testosterone Gel

This gel delivers testosterone to the bloodstream evenly in a timely manner and in a painless and non-invasive way, as it is a formulation of testosterone which is designed to be absorbed quickly through the skin after applying it on the upper arm once daily. With LibiGel’s topical application, there are no skin reactions, compared to other forms of transdermal delivery systems like patches for example.

The idea of the development program of LibiGel is quite fascinating in that it aims to develop a product to treat women who suffer from female sexual dysfunction, a discomfort that has no clinical tests or approved Food and Drug Administration products. They formulate this gel with a drug that will prove to be effective, safe, and affordable for women to use and also to develop. The design of the LibiGel program is to provide a safe and improved sexual desire in women and to increase the regularity of sexual satisfaction, and to decrease the personal grief that is linked to low sexual desire in women with hypoactive sexual desire disorder or as it is referred to—HSDD. LibiGel could be the first product approved by the Food and Drug Administration to treat Female Sexual Dysfunction or FSD and in particular, hypoactive sexual desire disorder in women during menopause.

Testosterone is also present in women but its deficiency decreases female sex drive and libido. Testosterone however is principally a male’s hormone. Clinical research shows that testosterone therapy improves mood swings, increases bone density, and boosts energy levels. Testosterone is also shown to increase sexual desire and activity and decrease sexual distress. In order to relieve the symptoms of hypoactive sexual desire disorder, treatment given to pre-menopausal women increases the serum testosterone to a normal range.

Regulatory Status – Development

Phase II Results

In the study of treatment with LibiGel in BioSante’s Phase II clinical testing, the effective doses of LibiGel produces levels testosterone blood in the normal range for pre-menopausal women, and has the same safety reports as the placebo group. Additionally, there were no serious adverse effects and no cessation occurred in any of the subjects who received LibiGel, due to adverse effects. The Phase II Clinical test was a double-blind, placebo-controlled testing, which was conducted in the United State in surgically menopausal women who suffered low sexual desires and activity. Treatment with LibiGel in BioSante’s Phase II clinical tests increased sexual activity significantly in surgically menopausal women who suffered from Female Sexual Dysfunction.

Plans and Progress in Phase III

The Food and Drug Administration concluded the LibiGel in BioSante’s Phase II clinical testing on January 24, 2008, and notified BioSante that it had arrived at an agreement with BioSante on a Special Protocol Assessment for BioSante’s Phase III safety and efficiency clinical tests of LibiGel in the treatment of hypoactive sexual desire disorder. Women who suffer from female sexual dysfunction and hypoactive sexual desire disorder are really experiencing discomfort and impediment in their sexual life, and the clinical tests that were conducted by BioSante are confirmed by the Food and Drug Administration that these intimate problems in women are in fact real and measureable and can be evaluated and deserve therapeutic attention. The Food and Drug Administration agrees that LibiGel Phase III efficiency and safety clinical test design, sample size, statistical analyses, planned conduct, and clinical endpoints are acceptable to support regulatory approval, thus the Special Protocol Assessment confirms this tests and statement made by the Food and Drug Administration. This then provides the assurance that the measures agreed upon will serve as the foundation for regulatory review and the decision by the Food and Drug Administration to approve a new drug application for LibiGel. The two Phase III and efficiency testing have begun, and are placebo-controlled, double-blind tests, that will include approximately 500 surgically menopausal women for six months of treatment.

The uncertainty of safety issues of testosterone therapy in women has been a question of efficacy, although there are no clinical statistics that show that a low dose of testosterone causes any serious unfavorable reaction in women. To ensure the safety of drugs during development and on the market, BioSante has come to an agreement with and has worked with the Food and Drug Administration to develop a program for LibiGel that is clinically realistic, dependable, and affordable. BioSante and the Food and Drug Administration have made an agreement to develop patented classification that would lead to the approval of LibiGel to treat female sexual dysfunction. BioSante has already begun to conduct one Phase III cardiovascular safety study of LibiGel, in addition to the prior two Phase III safety efficiency tests mentioned above. Approximately between 2,400 and 3,100 women tested who are exposed to LibiGel or placebo for 12 months undergo a random safety study of placebo-controlled, double-blind, multi-center, cardiovascular procedures. After 12 months, BioSante will submit a LibiGel new drug application for the review and approval by the Food and Drug Administration. For an additional four years, BioSante will continue to follow the women enrolled in the safety study, after the new drug application has been submitted and the likely approval of LibiGel.

The goal of LibiGel safety study is to illustrate the relative safety of testosterone compared to placebo in number of cardiovascular readings. Throughout the study, they are also doing a follow-up on the occurrence of breast cancer.

LibiGel safety group is studying multiple cardiovascular illnesses including myocardial infarction, cardiovascular death, and stroke in women age 50 and older who suffer from female sex dysfunction.

According to BioSante, it will take about 12 months to enroll the women in this multi-national cardiovascular safety test. BioSante expects to be able to file the LibiGel new drug application in 2010 for potential approval and introduction in 2011. It is evident that the safety trial is what will determine the timeline of the new drug application.

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