ObjectiveThis study was conducted to determine the effects of TTP in naturally menopausal (NM) women with hypoactive sexual desire disorder (HSDD).DesignRandomized, double-blind, placebo-controlled clinical trial.Materials and methodsNM women with HSDD on stable doses of oral estrogen with/without progestin received placebo (PL) or TTP 300 mcg/d twice weekly in a 24-week, randomized, double-blind, multi-center trial. The primary endpoint was the frequency of total satisfying sexual activity from the Sexual Activity Log (SAL) at 24 weeks. A pre-specified step-down analysis was conducted in women with SHBG ≤160 nmol/L, followed by the intent-to-treat population (ITT). Sexual desire was assessed with the Profile of Female Sexual Function (PFSF), and distress was assessed with the Personal Distress Scale (PDS). Adverse events (AEs) were also evaluated.Results549 women were enrolled (mean age 54 yrs). At 24 weeks, TTP significantly increased total satisfying episodes vs PL (SHBG ≤160 group: mean increase 2.1 vs 0.5 episodes/4wk, p< 0.0001; ITT: 1.9 vs 0.5 episodes/4wk, p< 0.0001) and vs baseline (SHBG ≤160 group: 78%; ITT: 73%). Improvements in desire and personal distress for TTP vs PL and baseline were statistically significant and similar in the SHBG ≤160 and ITT groups (see table). There were significant improvements in all other PFSF domains (arousal, orgasm, pleasure, concerns, responsiveness, self-image, p≤0.01). The overall incidence of AEs was 79% TTP and 73% PL. The incidence of androgenic AEs was low with a slightly higher incidence in the TTP group vs PL; 95% were mild, <1% resulted in study withdrawal.Conclusion ObjectiveThis study was conducted to determine the effects of TTP in naturally menopausal (NM) women with hypoactive sexual desire disorder (HSDD). This study was conducted to determine the effects of TTP in naturally menopausal (NM) women with hypoactive sexual desire disorder (HSDD). DesignRandomized, double-blind, placebo-controlled clinical trial. Randomized, double-blind, placebo-controlled clinical trial. Materials and methodsNM women with HSDD on stable doses of oral estrogen with/without progestin received placebo (PL) or TTP 300 mcg/d twice weekly in a 24-week, randomized, double-blind, multi-center trial. The primary endpoint was the frequency of total satisfying sexual activity from the Sexual Activity Log (SAL) at 24 weeks. A pre-specified step-down analysis was conducted in women with SHBG ≤160 nmol/L, followed by the intent-to-treat population (ITT). Sexual desire was assessed with the Profile of Female Sexual Function (PFSF), and distress was assessed with the Personal Distress Scale (PDS). Adverse events (AEs) were also evaluated. NM women with HSDD on stable doses of oral estrogen with/without progestin received placebo (PL) or TTP 300 mcg/d twice weekly in a 24-week, randomized, double-blind, multi-center trial. The primary endpoint was the frequency of total satisfying sexual activity from the Sexual Activity Log (SAL) at 24 weeks. A pre-specified step-down analysis was conducted in women with SHBG ≤160 nmol/L, followed by the intent-to-treat population (ITT). Sexual desire was assessed with the Profile of Female Sexual Function (PFSF), and distress was assessed with the Personal Distress Scale (PDS). Adverse events (AEs) were also evaluated. Results549 women were enrolled (mean age 54 yrs). At 24 weeks, TTP significantly increased total satisfying episodes vs PL (SHBG ≤160 group: mean increase 2.1 vs 0.5 episodes/4wk, p< 0.0001; ITT: 1.9 vs 0.5 episodes/4wk, p< 0.0001) and vs baseline (SHBG ≤160 group: 78%; ITT: 73%). Improvements in desire and personal distress for TTP vs PL and baseline were statistically significant and similar in the SHBG ≤160 and ITT groups (see table). There were significant improvements in all other PFSF domains (arousal, orgasm, pleasure, concerns, responsiveness, self-image, p≤0.01). The overall incidence of AEs was 79% TTP and 73% PL. The incidence of androgenic AEs was low with a slightly higher incidence in the TTP group vs PL; 95% were mild, <1% resulted in study withdrawal. 549 women were enrolled (mean age 54 yrs). At 24 weeks, TTP significantly increased total satisfying episodes vs PL (SHBG ≤160 group: mean increase 2.1 vs 0.5 episodes/4wk, p< 0.0001; ITT: 1.9 vs 0.5 episodes/4wk, p< 0.0001) and vs baseline (SHBG ≤160 group: 78%; ITT: 73%). Improvements in desire and personal distress for TTP vs PL and baseline were statistically significant and similar in the SHBG ≤160 and ITT groups (see table). There were significant improvements in all other PFSF domains (arousal, orgasm, pleasure, concerns, responsiveness, self-image, p≤0.01). The overall incidence of AEs was 79% TTP and 73% PL. The incidence of androgenic AEs was low with a slightly higher incidence in the TTP group vs PL; 95% were mild, <1% resulted in study withdrawal. Conclusion