Abstract Context: Hypoactive sexual desire disorder (HSDD) is one of the most common sexual problems reported by women, but few studies have been conducted to evaluate treatments for this condition. Objective: The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD. Design: The design was a randomized, double-blind, parallel-group, placebo-controlled, 24-wk study (the Intimate SM 1 study). Setting: The study was performed at private or institutional practices. Patients: The subjects studied were women, aged 26–70 yr, with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy. Placebo (n = 279) or testosterone 300 μg/d (n = 283) was administered. There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 μg/d testosterone group. Intervention: Testosterone (300 μg/d) or placebo patches were applied twice weekly. Main Outcome Measure(s): The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk. Secondary end points included other sexual functioning end points and safety assessments. Results: At 24 wk, there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group, which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group (P = 0.0003). The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress. The overall safety profile was similar in both treatment groups. Conclusion: In the Intimate SM 1 study, the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial.
6148 Background: Patient advocates are increasingly involved in cooperative group trials, single-institution cancer programs, and peer review of research applications. We sought to evaluate the role and value of advocates from the perspective of CALGB advocates and lead cooperative group investigators. Methods: We developed an online survey for current and past (within 5 years) advocates and investigators (committee chairs, cochairs, study chairs, and protocol coordinators). Email reminders were sent to maximize response rates. Fisher's exact test were performed; p < 0.05 was considered significant. Results: Response rates were 72.7% (16/22) for advocates, 56.4% (102/181) for investigators. Significant differences were: 100% of advocates vs. 72% of investigators reported the clinical trial process benefited from advocate involvement (p = 0.019); advocates were more likely than investigators to believe that advocates contribute substantially to protocol development, cultural appropriateness, and accrual (p < 0.001); and to perceive advocate involvement in concept development and protocol review as valuable (p < 0.01). One-third of advocates and investigators reported gaps in advocate knowledge and suggested additional clinical trials training was needed. To improve clinical trials, advocates suggested earlier involvement in protocol development and additional support from investigators, and investigators recommended improving advocate selection and communication skills training. Conclusions: The majority of advocates and investigators perceive benefits from advocate involvement in the clinical trials process; advocates placed more value on the role than investigators. Strategies to improve advocacy training and advocate-investigator communication may further enhance the role of advocates, and further studies that clarify the role of advocates in the prioritization and development of protocol, consent, and education materials, and on patient accrual, are warranted. No significant financial relationships to disclose.
Now bigger, better, and with more guilt: a completely revised, updated, and expanded second edition (would it hurt to have a little more?) of as a Second Language, the hilarious field guide to Jewish language and culture. Written to help her Gentile husband and others like him who fall for believing a Jewish mother-in-law when she says, Don't bother driving me, I'll take a cab, as a Second Language shows how to be one of the family how to worry, how to interrupt, how to change your hotel room. It's not Yiddish. Though non-Jews can endear themselves by learning how to mis-use words like schmendrick and schmatta providing both laughs and confirmation of Jewish superiority this Jewish language is about the complex twists and somersaults of everyday speech, of unexpected nuances, hidden meanings, and swampy thickets of behavior, of wins, losses, and draws in competitions you never knew you entered. It's about the most common OAQs (obsessive anal questions): This mole looks okay, doesn't it? Can Saltines go bad? They'll de-ice the wings before takeoff, right? The Four Basic Shrugs. Acronyms never to use again: NASCAR, STD, and MRSA (Methicillin Resistant Staphylococcus Aureus, the potentially deadly skin virus that s spread by contact, and also by talking about it casually). The things non-Jews do for fun and what Jews do: Contra dance/Contradict, Read the comics/Read the obituaries, Get your boobs done/Get your taxes done. Stuff never found in a Jewish home (trout flies, a lineoleum knife, a Lay-Z-Boy, a rottweiler) or mouth (Miracle Whip, marshmallow fluff, Bud). So you'll sit, you'll read, you'll laugh until you're nauseous. It's a nice book.
Oophorectomy reduces serum testosterone levels. We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women.A 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial was conducted in women (aged 24-70 years) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy. Women were randomized to receive placebo (n = 119) or testosterone patches in dosages of 150 microg/d (n = 107), 300 microg/d (n = 110), or 450 microg/d (n = 111) twice weekly for 24 weeks. Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures.Of the 447 women randomized, 318 (71%) completed the trial. Compared with placebo, women receiving the 300-microg/d testosterone patch had significantly greater increases from baseline in sexual desire (67% vs 48%; P = .05) and in frequency of satisfying sexual activity (79% vs 43%; P = .049). The 150-microg/d group showed no evidence of a treatment effect. The 450-microg/d group also was not statistically different from the 300-microg/d or placebo groups. Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks (P = .06 and .06, respectively). Adverse events occurred with similar frequency in both groups; no serious safety concerns were observed.The 300-microg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause.
