Clinical Trials

Happy Family Store by Biosante pharmaceuticals is a corporation oriented towards the research and development of new therapies in the first place. As of today, it is mostly known for its products for male and female sexual health such as LibiGel, Bio-T-Gel, Elestrin.

Yet, we are always seeking new opportunities to contribute to the health and wellbeing of our clients and the global community in general. Thus, we are constantly working on a wide scope of new products intended for use in diversified therapeutic fields.

Here are the most recent studies by our pharma development company:

1. An extension study to evaluate the persistence of LibiGel benefits (Phase III). The objective is to compare the persistence of benefits provided to health by our 1% testosterone gel and by placebo gel in surgically menopausal women suffering from hypoactive sexual desire disorder. LibiGel is a topical gel with testosterone for treating adverse symptoms of menopause and a post-menopausal period, namely hot flashes and a decrease in sexual desire. To assess the persistence of the benefits, our clinical team is analyzing the changes in the number of satisfying sexual events after the withdrawal of products mentioned.
2. A study on the safety and efficacy of LibiGel in surgically menopausal women (Phase III). The objective is to compare the effect of the testosterone gel under study with that of placebo gel. To evaluate the effectiveness and safety of these two products, we are analyzing changes in the number of satisfying sexual events, the ISED desire score, and a range of other efficacy measurements.
3. A study on the safety and efficacy of LibiGel in postmenopausal women (Phase III). For this trial, we involved volunteers diagnosed with hypoactive sexual desire disorder and having at least two points of cardiovascular risk. All of them are at least 50 years old. To assess the safety of the 1% testosterone transdermal gel developed by our company, we will analyze its action in comparison with that of placebo gel. Namely, we are going to check the frequency of adjudicated and predefined cardiovascular events in women taking our product and placebo.
4. A study on the safety and effectiveness of Elestrin in postmenopausal women (Phase III). This medicine is a topical estradiol gel for treating negative symptoms associated with menopause. In this trial, we focused on vasomotor symptoms and vulvovaginal atrophy. The estradiol gel developed by our company is aimed at normalizing estrogen levels in menopausal and postmenopausal periods and releasing patients from negative symptoms of these states. In the trial, we compared the action of Elestrin with that of placebo gel. And, to evaluate the effectiveness of our product, we monitored the frequency of hot flashes and their severity in volunteers taking both products. Besides, we asked participants to self-evaluate the state of their vaginal health. One more method was an examination by a physician.
5. A neoadjuvant study of the effectiveness of the combined use of androgen ablation, Cyclophosphamide, and GVAX vaccine (Phase II). This trial is intended to determine whether it is safe to apply the localized prostate cancer vaccine together with a Cyclophosphamide intravenous injection and standard hormonal therapy in male patients that plan to undergo surgery for the removal of prostate glands. The vaccine mentioned is meant to stimulate the immune system to actively respond to tumors. But the preclinical studies have shown that it is not effective enough when used individually. That is why we seek other therapies that have the potential to intensify its action. In this trial, we will apply the combination of the products mentioned and see how that will affect the hormone, antibody, and antigen levels in patients within a 3-year period, i.e. how that will impact the risk of prostate cancer recurrences.