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BioSante’s libido boosting testosterone drug LibiGel improves bone mineral density in HIV+ women

Wednesday, June 3, 2009, 12:23 This news item was posted in health category and has 3 Comments so far.

LibiGel, a testosterone gel currently being studied to enhance sexual drive in women, is found to be improving body composition including bone mineral density in HIV infected women.

LibiGel, which is being developed by BioSante Pharmaceuticals, Inc is a low dose testosterone gel meant for the treatment for menopausal women with low sexual drive or hypoactive sexual desire disorder (HSDD).
A study using LibiGel in HIV infected women has come out with the finding that the testosterone gel is well-tolerated in HIV-infected women and resulted in significant improvement in body composition, bone mineral density (BMD), and quality of life indices.

Results of a randomized, placebo-controlled trial of testosterone in HIV-infected women are reported in a paper published in the May 15, 2009 issue of AIDS, the Journal of the International AIDS Society.

The 18-month study was conducted in 25 HIV-infected women belonging to the average age of 43-45 years old with free testosterone below the normal female range. The women were randomized to testosterone (300 micrograms per day delivered by patch) or identical placebo. The study was conducted at Massachusetts General Hospital (MGH) and Massachusetts Institute of Technology (MIT). The study was funded by the NIH (National Institutes of Health) and the Harvard Clinical Center For Research Resources.
“These newly published testosterone data are very exciting for many reasons,” said Stephen M. Simes, BioSante president and CEO.
BioSante is in late-stage development of LibiGel testosterone, at the same dosage employed in the published study, for the treatment of HSDD in menopausal women.

Mr Simes said BioSante was conducting three LibiGel Phase III clinical trials including the first large long-term cardiovascular and breast cancer safety study of testosterone in women.

The newly published data were positive for the new potential use of LibiGel in HIV-infected women. Women, whether HIV-infected or not, deserve the same options for therapy as men have had for many years, he said.
The phase III study using LibiGel is the first to investigate the effects of testosterone use over 18 months among HIV-infected women, and shows that testosterone is well tolerated over a long treatment period, according to the authors of the published paper. 

The study also found testosterone had no significant effect on lipid levels, including high-density lipoprotein, and study-related adverse events were similar between the testosterone and placebo groups without significant differences in hirsutism (hair growth), hair pattern, acne or changes in menstrual pattern.

No testosterone subjects withdrew from the study due to adverse events. No serious study-related adverse events occurred during the randomized portion of the study.
Low androgen levels are common among HIV-infected women. Women with HIV are known to have reduced BMD, lean body mass, and reduced quality of life. Low androgen may contribute to such changes; yet no treatment strategies exist for women, and research investigating sex-specific treatment strategies in HIV-infected women has been limited, the authors commented.

However, treatment of hypogonadism is routine among HIV-infected men as it improves body composition, BMD, and depression.

LibiGel study data showed that testosterone treatment, at the same low daily dose being used in BioSante’s LibiGel studies, is well tolerated over 18 months and results in significant improvements in body composition, BMD and quality of life.
LibiGel: Libido booster for women

LibiGel is a gel formulation of testosterone, designed to be quickly absorbed through the skin. This once-daily application when applied on the upper arm, delivers testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. The topical application of LibiGel has the added advantage of reduced skin reactions compared to other forms of transdermal delivery systems
On January 24, 2008, the US FDA notified BioSante that it had completed and reached agreement with BioSante on a Special Protocol Assessment (SPA) for BioSante’s Phase III safety and efficacy clinical trials of LibiGel in the treatment of HSDD.

Both Phase III safety and efficacy trials using LibiGel are underway and are double-blind, placebo-controlled trials that will enroll approximately 500 surgically menopausal women each for six-months of treatment.
In addition to the two Phase III safety and efficacy trials, BioSante is conducting one Phase III cardiovascular safety study of LibiGel. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months.

BioSante expects to be able to file the LibiGel NDA in 2010 for a potential approval and launch in 2011.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. Apart from LibiGel BioSante’s lead products include Elestrin and Bio-T-Gel .

Elestrin (estradiol gel) is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S.

Bio-T-Gel, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II/III clinical development using BioSante patented technology.

The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company is also developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook).

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3 Responses to “BioSante’s libido boosting testosterone drug LibiGel improves bone mineral density in HIV+ women”

  1. Kaitlyn Libido said on Wednesday, June 3, 2009, 21:50

    Day of oral estriol and 1, day of calcium lactate versus 1, day calcium lactate alone. Kaitlyn Libido

  2. ASGT 12th Annual Meeting: Gene Therapy Controls HIV, Research Shows | Aids Discussion said on Wednesday, June 3, 2009, 23:17

    […] LibiGel improves bone mineral density in HIV+ women, testosterone … […]

  3. Apostle Shada Mishe said on Friday, June 5, 2009, 4:30


    THE IDEA that AMBUSH cures AIDS
    is being proven by the more than 400 individuals who have taken a dose of 60 ml three times daily for 21 days. The result is that AMBUSH ‘KILLS’ the virus by causing the protein envelope to rupture and the viral particles are discarded by the white blood cells. AMBUSH is able to ‘KILL’ the virus that are ‘hiding’ in the lymph system by its ‘natural radioactive’ properties. This process allows the body to ‘return to normal health’ with a corresponding immunity to that or those strains of the virus.

    What is AMBUSH ?
    AMBUSH is a radioactive isotope of uranium that is found in the ‘palm’ plant of which there are more than 3000 species. When ingested, AMBUSH causes the body temperature in the trunk area to rise to about 102 degrees when the individual is sleeping. The preparation takes four hours per batch, which is then given to the individuals for consumption 60 ml three times daily for 21 days. AMBUSH is a herbal preparation in this form but it contains an active ingredient which is a ‘NEW’ crystalline substance, a drug from the ‘palm plant’ similarly to ASPIRIN originating from the willow tree bark

    After 21 days on AMBUSH, ALL the individuals experienced a decrease in viral load to undetectable, an increase in cd4, increase in RBC, an improvement in general health such as more color to the face, decrease in Buffalo hump, an increase in gluteal muscles, a decrease to having no joint pains whereby individuals can bend to touch their toes, and walk up steps are but a few examples. There is also a dramatic increase in their sexual appetite beginning after the first week of therapy

    In any plant concoction such as percolated ‘tea’, there are 30-40,000 compounds, whi ch would take the scientific community twenty years to isolate one particular ingredient if they knew what they were looking for. The LORD GOD has given me seven steps to isolate the active ingredient, which is soft and metallic in nature and has a carbon- uranium-sulfur-(classified)-phentolamine configuration or structure. This is similar to Federick Kekule and the discovery of the benzene ring where he dreamt the structure.

    As an antiviral and ‘natural radioactivity’ producing agent, AMBUSH is also effective against leukemia, lupus and HPV. Here I am saying that I have ‘GIVEN’ AMBUSH in the same ‘strength’ and dosage to patients with leukemia, lupus and HPV. A 35 year old male with HIV found it difficult to impossible to urinate was put on ‘green tea’ and water while the doctors contemplated prostrate surgery. One of the doctors gave him my number , I sent him a supply of AMBUSH an d he has not been given any more ARV’s, since taking AMBUSH 18 months ago, is in ‘good’ health and has expressed a willingness to be examined by HIV investigators like many others who have taken AMBUSH.

    I have sent this ‘IDEA’ to most HIV research agencies, scientist of the field, universities, hospitals, clinics, politicians and news agencies to which it is REJECTED because the name of THE LORD GOD is mentioned. He has steered me scientifically through the processes such as which plant and how to produce the active ingredient. What are the odds of a Florida Pharmacist picking a plant would contain the CURE for HIV/AIDS ?
    I have never charged any of the people for their supply of AMBUSH but a life saving has been spent on the project with NO renumeration from any sources because AMBUSH falls outside the walls of modern medicine and research.


    My proposal is that I PROVE that AMBUSH CURES HIV/AIDS by giving it to a number of END-STAGE or DRUG-RESISTANT people and the scientific community watches their recovery. This proposal addresses the problem in that I have already outlaid the results to be obtained.

    This IDEA is unconventional in that the scientific community has rejected AMBUSH because I say it is GOD given. Secondly if I wrote it according to certain standards, then it might be peer reviewed. However, THE LORD GOD has also shown me that there are five enzyme systems associated with the virus, reverse transcriptase, protease, fusion and two more of which causes the virus to be AIRBOURNE. This means that without DIVINE intervention mankind and ALL warm- blooded mammals will be extinct in a number of years.

    The PROOF of what I am saying is found in scientific papers wherein it is found that when the protease cuts the viral strands, it cuts it at DIFFERENT lengths EVERY time, to which it should always be a valine at the end but is a different amino acid every time. This is why it is IMPOSSIBLE to produce a VACCINE.

    Since this is NOT a hypothesis but there are about 400 individuals who have taken AMBUSH, here lies a vast area in which to check, recheck and confirm that AMBUSH CURES AIDS. Let it be mentioned that during the HIV reproductive cycle, reverse transcriptase converts viral RNA into DNA compatible to human genetic materials. Thus the human DNA has been ‘hijacked’ and since each person has a DIFFERENT DNA, then the new viral copy is unique to that person which shows that each individual has a DIFFERENT STRAIN of the virus. Consider two HIV positive people swapping viral strains and increasing its complexity with multiple partners.
    It can also be proposed that they be revisited as proof that the strain or strains that they had were ‘killed’ at the time of taking AMBUSH considering that a person can catch as many different strains as there are people who are infected by HIV.
    I am also willing to work with the scientific community in identifying those individuals who took AMBUSH and wish to be identified with this process notwithstanding that some are stigmatized while others are jubilant,

    Once AMBUSH is verified as being able to accomplish that which is aforementioned then the next stage might be the natural and artificial synthesis of the substance.

    Finally, if this is accepted or not, believed or not, THE LORD GOD always wins and this is the heavenly truth to which AMBUSH was divinely given to mankind for the CURE of HIV/AIDS and it will be here forever. Apostle Shada Mishe.


    Here is a video taped presentation that I gave at t he Martin Luther King library in Washington


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