Introduction Although the new classification of premature ejaculation (PE) has been proposed by Waldinger et al., there have been few studies investigating the four PE syndromes in China. Aims We investigated the prevalence and factors associated with the complaint of PE and the four PE syndromes in Anhui province, China. Methods Between September 2011 and September 2012, subjects were selected from five cities in Anhui province, China. They participated in this survey by completing a detailed verbal questionnaire regarding their demographic data and medical and sexual history. Men with PE complaint were diagnosed as lifelong PE (LPE), acquired PE (APE), natural variable PE (NVPE), or premature-like ejaculatory dysfunction (PLED). Main Outcome Measures PE complaint was divided into four PE syndromes. Anxiety, depression, and erectile dysfunction were independently assessed by the self-rating anxiety/depression scale and the international index of erectile function-5, respectively. Results Of the 3,016 men evaluated, 25.80% complained of PE. The distribution of the four PE syndromes in men with PE complaint was in the order of NVPE (44.09%), PLPE (24.81%), APE (18.77%), and LPE (12.34%). Patients with PE complaint were older and more likely to smoke, had more comorbidities, and a higher body mass index (BMI) than patients without the complaint (P < 0.001 for all). Similar findings were also observed in patients with APE compared with other PE patients (depression P = 0.012, cardiovascular P = 0.003, others P < 0.001). In addition, the rates of counseling by a doctor in men with LPE and APE were higher than those in men with NVPE and PLED (P < 0.001). Conclusion The prevalence of PE complaint in male population of Anhui province, China, was 25.80%, with the highest PE syndromes being NVPE and PLPE. Patients with PE complaint or APE were older and more likely to smoke, had more comorbidities, and a higher BMI.

NCT01441635.

Introduction Although infertility is known to be associated with psychological and sexual problems, the relationship between these two aspects in infertile men has not been well investigated. Aim To investigate the incidence of sexual dysfunction and psychological burden, and their possible associations in infertile men. Methods From June 2009 to June 2012, a total of 1,468 infertile men and 942 fertile men were evaluated. Premature ejaculation (PE) and erectile dysfunction (ED) were measured by the PE diagnostic tool (PEDT), the intravaginal ejaculatory latency time (IELT) and the international index of erectile function (IIEF)-5. Anxiety and depression, which reflect the degree of psychological burden, were measured by the self-rating anxiety scale (SAS) and self-rating depression scale (SDS), respectively. Main Outcome Measures PE and ED were measured by the PEDT, IELT, and IIEF-5. Anxiety and depression were measured by the SAS and SDS, respectively. Results The incidences of PE and ED in the infertile group were significantly higher than those in the fertile group (PE: 19.01% vs.10.93%, P < 0.001; ED: 18.05% vs. 8.28%, P < 0.001). In addition, anxiety and depression were more prevalent in infertile than fertile men (Anxiety: 38.01% vs. 26.65%, P < 0.001; Depression: 15.74% vs. 10.08%, P < 0.001). Furthermore, after adjusting for age in the infertile group, the PEDT score was positively associated with anxiety (adjusted r = 0.57; P < 0.001) and depression (adjusted r = 0.54; P < 0.001). Moreover, the IELT were negatively associated with anxiety (adjusted r = −0.40; P < 0.001) and depression (adjusted r = −0.52; P < 0.001). Similar negative relationships were also observed between the IIEF-5 score and anxiety (adjusted r = −0.49; P < 0.001) or depression (adjusted r = −0.50; P < 0.001). Conclusion This is the first study to systematically evaluate the incidence of sexual dysfunction and psychological burden, and their possible associations in infertile men in China. Further in-depth studies are needed to confirm and extend these results.

OBJECTIVE: To evaluate elagolix, an oral gonadotropin-releasing hormone receptor antagonist, alone or with add-back therapy, in premenopausal women with heavy menstrual bleeding (greater than 80 mL per month) associated with uterine leiomyomas. METHODS: This double-blind, randomized, placebo-controlled, parallel-group study evaluated efficacy and safety of elagolix in cohorts 1 (300 mg twice daily) and 2 (600 mg daily) with four arms per cohort: placebo, elagolix alone, elagolix with 0.5 mg estradiol/0.1 norethindrone acetate, and elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate. A sample size of 65 per group was planned to compare elagolix with add-back to placebo on the primary end point: the percentage of women who had less than 80 mL menstrual blood loss and 50% or greater reduction in menstrual blood loss from baseline to the last 28 days of treatment. Safety assessments included changes in bone mineral density. RESULTS: From April 8, 2013, to December 8, 2015, 571 women were enrolled, 567 were randomized and treated (cohort 1=259; cohort 2=308), and 80% and 75% completed treatment, respectively. Participants had a mean±SD age of 43±5 years (cohort 2, 42±5 years), and 70% were black (cohort 2, 74%). Primary end point responder rates in cohort 1 (cohort 2) were 92% (90%) for elagolix alone, 85% (73%) for elagolix with 0.5 mg estradiol/0.1 mg norethindrone acetate, 79% (82%) for elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate, and 27% (32%) for placebo (all P<.001 vs placebo). Elagolix groups had significant decreases compared with placebo in lumbar spine bone mineral density, which was attenuated by adding 1.0 mg estradiol/0.5 mg norethindrone acetate. CONCLUSION: Elagolix with and without add-back significantly reduced menstrual blood loss in women with uterine leiomyomas. Add-back therapy reduced hypoestrogenic effects on bone mineral density. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01817530; EU Clinical Trial Register, 2013-000082-37.