#Ntouch vp 300 Patch
#Ntouch vp 300 trial
#Ntouch vp 300 license

To participate, women with surgically induced menopause had to be 20 to 70 years of age and postmenopausal for at least 12 months women who had undergone natural menopause had to be 40 to 70 years of age and postmenopausal for at least 2 years. Women from 65 centers in the United States, Canada, Australia, the United Kingdom, and Sweden participated in the study between July 2004 and February 2006.

#Ntouch vp 300 Patch

We performed a double-blind, randomized, placebo-controlled study - A Phase III Research Study of Female Sexual Dysfunction in Women on Testosterone Patch without Estrogen (APHRODITE) - to determine the efficacy and safety of a testosterone patch (Intrinsa, Procter & Gamble Pharmaceuticals) for the treatment of hypoactive sexual desire disorder in women with natural or surgically induced menopause who were not receiving estrogen or estrogen plus progestin. 17-20 Data pertaining to the use of testosterone by postmenopausal women not receiving estrogen or estrogen plus progestin are lacking.

11-16 However, the long-term use of estrogen or a combination of estrogen and progestin has been associated with risks and is not routinely recommended. 8-10 Several studies have shown the efficacy and short-term safety of a transdermal patch delivering 300 μg of testosterone per day for the treatment of hypoactive sexual desire disorder in women who have undergone either surgically induced or natural menopause and who use concomitant estrogen. 5 Decreased libido is common after natural menopause 6,7 and bilateral oophorectomy. 1-4 Among these women, hypoactive sexual desire disorder is a commonly reported, symptom-driven condition characterized by a decrease or absence of interest in sexual activity, causing distress. The literature suggests that the prevalence of sexual problems among women ranges from 9 to 43%. The long-term effects of testosterone, including effects on the breast, remain uncertain. In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 μg of testosterone per day resulted in a modest but meaningful improvement in sexual function. Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo) one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. The rate of androgenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 μg of testosterone per day than in the placebo group (30.0% vs. As compared with placebo, both doses of testosterone were associated with significant increases in desire (300 μg per day, P<0.001 150 μg per day, P=0.04) and decreases in distress (300 μg per day, P<0.001 150 μg per day, P=0.04). ResultsĪt 24 weeks, the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 μg of testosterone per day than in the placebo group (an increase of 2.1 episodes vs. The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes. Efficacy was measured to week 24 safety was evaluated over a period of 52 weeks, with a subgroup of participants followed for an additional year.

#Ntouch vp 300 trial

We conducted a double-blind, placebo-controlled, 52-week trial in which 814 women with hypoactive sexual desire disorder were randomly assigned to receive a patch delivering 150 or 300 μg of testosterone per day or placebo. The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy are unknown. The most trusted, influential source of new medical knowledge and clinical best practices in the world.

#Ntouch vp 300 license

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