Hypoactive Sexual Desire Disorder (HSDD)

In the 20th century, we had witnessed astonishing progress in the field of Pharmaceutical Science. These progresses increased life expectancy, as many diseases are now curable or preventive. We might have read or heard about different diseases, but diseases related to Female Sexual Disorder (FSD) are not much talked compare to Male Sexual Disorder (MSD). Hypoactive Sexual Desire Disorder (HSDD), a condition or disease related to decrease sexual desire in females is much talked in medical fraternity or written in different medical literatures after “Viagra” had been approved by the United States Food and Drug Administration (FDA) in 1997 for the same medical condition in men. In the quest for a drug to treat female sexual dysfunction Proctor

In TDDS, a medicament enclosed in an adhesive polymer (permeable for drug) with the compatible backing layers (upper protective layer and impermeable for drug). Testosterone is an endogenous hormone in men and women, which is responsible for sexual desire (libido) in women. P&G had developed Intrinsa to treat HSDD in surgically menopausal women. P&G had conducted two trials in naturally menopausal women for safety for 6, 12, and 18 months, and two trials in surgically menopausal women for efficacy. Each drug has its own pros and cons, and Intrinsa was not different from other drug. Two of member countries for International Conference on Harmonization had a different opinion regarding Intrinsa`s advantages and disadvantages which leads to marketing approval by the European Medical Agency (EMEA) for Europe and rejected by the FDA for United States of

The main reasons behind rejection were absence of long time safety study, probable risk of breast cancer and cardio vascular problem. An androgens has antagonistic effect on estrogen and progesterone`s proliferative effects on breast cells which may lead to cancer, because androgenic receptor are presents on breast cells. The Women`s Health Initiative (by) studies of estrogen plus progesterone therapy not succeeded to show any positive results, but it showed that occurrence of breast cancer was 26% which was statistically significant according per study design. The incidences of breast cancer were aroused during third year of study. This WHI finding raised the question on Intrinsa, as it was for women patients who were on estrogen therapy. The androgenic effects of testosterone are well documented in medical journals from past researches. In another trial known as APHRODITE trial investigated effect of testosterone in postmenopausal women who are not on estrogen therapy showed that testosterone has capability to induce breast cancer. The Rancho Bernardo Study advocated Intrinsa`a cardio vascular effect as myocardial infraction. Lina Al-Imari and Wendy L.Wolfman had reviewed the safety of testosterone in women and concluded that clinical evidence advocates short term safety for