FDA clinical trials and results explained
Since 2001 BioSante has been conducting clinical trials on it's testosterone treatment LibiGel for the safe and effective use in aid of Female Sexual Dysfunction or FSD and Hypo Sexual Desire Disorder HSDD. To date there have been multiple effectiveness and safety trials conducted in order to meet FDA's strict regulations and be made available for sale and medical use within the United States. Other companies have tried this and failed in the past either for not being effective enough or safe enough to be administered according to the FDA. Many of you have wrote us for a clear description of the status and results of the multiple trials that LibiGel has undergone. We will try to outline here what has been presented, reported, and announced by BioSante to keep facts straight and misinformation avoided.
LibiGel Phase II Humane Clinical Trials
In 2001 BioSante announced that it would enter into human clinical trials for it's transdermal testosterone gel hormone therapy, LibiGel. These trials were to study the effectiveness and safety of the treatment. The results were pretty satisfactory in the study of over hundreds of surgically menopausal women. There were reportedly no serious or adverse side effects of LibiGel observed during the trials and the percentage of women who reported increase in sexual activity was well enough to sustain continued clinical trials for efficiency. There were also no discontinuations of usage by trial patients due to reactions or side effects which is a positive result for the study. As a result of the Phase II trials BioSante studied and confirmed an appropriate dosage of the LibiGel testosterone gel.
Phase III Trials underway now
Early 2008 was when BioSante received good news from the FDA. An agreement had been reached on a special protocol assessment for Phase III efficacy clinical trials to study safety and efficiency of the LibiGel treatment. This held a few crucial meanings for the pharmaceutical market most importantly confirmation that the FDA recognizes HSDD and FSD as legitimate conditions experienced by women with values that can be measured in terms of treatment effectiveness. It also also provides assurance that there can and will be regulatory measurements to be reached in order for BioSante to apply for and be approved for a new drug application which would most certainly be the goal of the company. Currently safety and efficacy trials are taking place in a double-blinded placebo study that is reportedly enrolling around 500 women who are surgically menopausal to subscribe to six months of treatment to be studied.
In order to comply with FDA standards BioSante will also be conducting a larger trial to study the potential for adverse cardiovascular side effects in addition to the above trials. A randomized double blinded study of more than 2,500 women to be exposed to either LibiGel or a placebo will be closely monitored for 12 months to study events including death, stroke, and myocardial infraction. The obvious objective is to provide solid measure of the safety and reliability of LibiGel and after the 12 month testing period BioSante has announced it plans to apply and submit an NDA for LibiGel's review and potential approval by FDA authorities. The pharmaceutical company has also stated that it will continue to closely monitor the trial patients for an additional 4 years after Phase III trials complete.
Is female Viagra here?
Only time will tell if LibiGel meets the stringent standards of the FDA. Safety is the apparent number one concern to be met and studied and there has not been success in the US for other similar treatments so Feminine Review will stand by and commit to reporting the most recent news and information on LibiGel Clinical Trials. Until then women probably continue to be prescribed off-label testosterone treatments for FSD and HSDD as there are no other FDA approved therapies in the US. There is also a surging market for natural and homeopathic remedies available today and some very well reviewed alternatives. Feel free to read through our articles and reviews for more information.