Use of a novel Testosterone gel in treatment of hypoactive ...



efficacy and safety of libigel™ - a novel Testosterone gel for DECREASED sexual desire

Leah M. Lehman, PhD1, Joanne G. Zborowski1, Stephen M. Simes1, James A. Simon, MD2, 1BioSante Pharmaceuticals, Inc., Lincolnshire, IL, USA, 2Women’s Health Research Center, Laurel, MD, USA.

Introduction: A low testosterone (T) level is one proposed cause of decreased sexual desire in women. Oophorectomized women lose approximately 50% of their T production. We evaluated the effects of our topical testosterone gel (LibiGel™) to determine the efficacy and safety of three doses of LibiGel™ in women with low libido following surgical menopause.

Methods: The study was a Phase II, multicenter, double-blind, placebo-controlled, randomized study of surgically menopausal women with hypoactive sexual desire disorder (HSDD). Forty-six women with low serum free T concentrations, low sexual desire causing distress, and receiving a stable dose of estrogen were enrolled. The study consisted of an eight-week Pretreatment Period and a 12-week Double-Blind Treatment Period. Eligible subjects were equally randomized to one of four treatment arms: low-dose LibiGel, mid-dose LibiGel, high-dose LibiGel, or matching placebo gel. Sexual activity, level of sexual desire and frequency of facial depilation were recorded in a diary for 12 weeks. Sexual function and mood questionnaires were completed prior to randomization and at the final visit. Serum trough T, free T, bioavailable T, DHT and SHBG samples were drawn at each visit. The primary analysis was the change from baseline in 4-week sexual event rate over the 3 month treatment period. Other efficacy assessments included a daily desire score, sexual and mood questionnaires, and a global efficacy question. Safety assessments included collection of adverse events, laboratory assessments, and hirsutism, acne, and skin application assessments.

Results: After 3 months of treatment, an increase from baseline in 4-week sexual event rate was observed in all LibiGel dose groups. The mean change from baseline in the 4-week sexual event rate at Week 12 was statistically significant (p≤ 0.05) for the mid-dose LibiGel group as compared to placebo. Median serum free T, bioavailable T, and DHT values did not exceed their respective normal ranges for all LibiGel doses. Median SHBG values did not change significantly during the treatment period. No significant adverse events occurred and no significant changes were observed on any safety parameters.

Conclusions: These results indicate that LibiGel is effective in the treatment of HSDD in surgically menopausal women. All LibiGel dosages were well tolerated with no relevant differences in the safety profile of the three dosage strengths investigated as compared to placebo.

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