I was originally sceptical, but if you look at the results of phase II trials as well as the Intrinsa trials that the Nutsyprofessor has researched. He has made a compelling argument a for something being out of whack with this placebo. It appears to have performed much better then any other placebo in the past. Sexual appetite is very subjetcive, but when they measured testosterone levels the placebo barely moved. Libigel won hands down. As I understand it, the Bloom trials proved that HSDD can be treated with a product designed for women.
I believe the criteria for inclusion and exclusion was set by the FDA or at least they exerted a lot of influence.
Since Viagra has developed a reacreational black market for perfomance enhancement,I wonder if the FDA or Bioasante wanted to measure this in the test as well, by including non-HSDD women in the trial (it was not the intended audience of this product). The safety trial criteria included post menopausal surgical or natural with HSDD diagnosis.
Efficacy
Inclusion Criteria:
•Must be between the ages of 30 to 65 years
•Must have undergone hysterectomy and bilateral salpingo-oophorectomy
Exclusion Criteria:
•A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
•Any systemic skin diseases or local skin abnormalities in the area of application
•Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
•A medical condition that could affect or interfere with sexual function
•Using a systemic transdermal gel or cream estrogen therapy.
Results from the safety trials should come out in June 2012. This will produce a wealth of knowledge as well.
Safety
Inclusion Criteria:
Postmenopausal female subjects
•at least 50 years of age
•with at least two points of cardiovascular risk
•with a clinical diagnosis of HSDD.
Exclusion Criteria:
Subjects must not
•require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators,
•have used androgen therapy within 2 months of randomization,
•have a history of estrogen-dependent neoplasia or any gynecologic cancer,
•have a history of cancer of any kind in the past 10 years prior to randomization,
•have a history of malignant melanoma or a history of invasive cancer at any time,
•have a screening mammogram with any finding that requires follow up within 6 months of randomization,
•have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization,
•have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.
It almost appears as they used the efficacy, extention and safety trials to cover as many bases as possible. The Safety results is really the prize. With good results they have a product, the post hoc analysis will determine how big the prize is going to be.
Personnaly I believe GVAX will be the product to have Biosante reach it's true potential. Libigel will just get them there faster.
