The journal of sexual medicine
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Randomized Controlled Trial
The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX).
Cligosiban is an orally administered, centrally penetrant oxytocin receptor antagonist being developed to treat premature ejaculation (PE). ⋯ Cligosiban was well tolerated but failed to demonstrate efficacy for the treatment of men with lifelong PE at doses up to 1200 mg. Althof S, Osterloh IH, Muirhead GJ, et al. The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX). J Sex Med 2019; 16:1188-1198.
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Randomized Controlled Trial
Summative Usability Evaluation of the SCTE-AI Device: A Novel Prefilled Autoinjector for Subcutaneous Testosterone Administration.
The subcutaneous testosterone enanthate (TE) autoinjector (SCTE-AI) is a single-use, pre-filled, disposable autoinjector intended for testosterone (T) self-administration in adult males with T deficiency. ⋯ Results of this usability validation study indicate that the SCTE-AI device is safe and intuitive to use, with a low potential for harm and is associated with a high rate of injection success, regardless of prior training or experience. Arora S, Moclair B, Murphy K, et al. Summative Usability Evaluation of the SCTE-AI Device: A Novel Prefilled Autoinjector for Subcutaneous Testosterone Administration. J Sex Med 2018;15:1707-1715.
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Randomized Controlled Trial
Pharmacokinetics, Safety, and Tolerability of Single Oral Doses of a Novel Oxytocin Receptor Antagonist-Cligosiban-in Development for Premature Ejaculation: Three Randomized Clinical Trials in Healthy Subjects.
Cligosiban is a selective oxytocin receptor antagonist being developed for the treatment of premature ejaculation (PE). ⋯ Cligosiban had a good safety/tolerability profile at doses predicted to be therapeutic or supra-therapeutic and a pharmacokinetic profile appropriate for "as-needed" dosing for men with PE. Osterloh IH, Muirhead GJ, Sultana S, et al. Pharmacokinetics, Safety, and Tolerability of Single Oral Doses of a Novel Oxytocin Receptor Antagonist-Cligosiban-in Development for Premature Ejaculation: Three Randomized Clinical Trials in Healthy Subjects. J Sex Med 2018;15:1547-1557.
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Randomized Controlled Trial
Comparison of the Effect of Intermittent and Continuous Aerobic Physical Training on Sexual Function of Women With Polycystic Ovary Syndrome: Randomized Controlled Trial.
Polycystic ovary syndrome (PCOS) is a common condition characterized by hyperandrogenism, anthropometric changes (increased weight and waist-to-hip ratio [WHR]), behavioral changes (sexual dysfunction, anxiety, and depression), and reduced quality of life. Physical exercise may reduce many of the adverse effects of PCOS. However, no studies have yet evaluated the effects of aerobic exercise on the sexual function of women with PCOS. ⋯ The CAT and IAT protocols improved the sexual function and reduced the anxiety and depression of women with PCOS. Both protocols were similar to improve FSFI domain scores. Lopes IP, Ribeiro VB, Reis RM, et al. Comparison of the Effect of Intermittent and Continuous Aerobic Physical Training on Sexual Function of Women With Polycystic Ovary Syndrome: Randomized Controlled Trial. J Sex Med 2018;15:1609-1619.
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Randomized Controlled Trial
Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial.
Low-level laser therapy (LLLT) is an emerging medical technology in which non-thermal laser irradiation is applied to treat pain. Because LLLT has been found effective in treating various pain syndromes without known side effects, we conducted a study evaluating the effect of LLLT on provoked vestibulodynia (PVD), a complex sexual pain disorder characterized by pain confined to the vulvar vestibule in response to contact or pressure. ⋯ Given the results of this pilot study, LLLT cannot currently be recommended as a treatment for PVD. Further studies with a larger population, various treatment protocols, and evaluation of LLLT in different subgroups of PVD are needed to define which patients can benefit from this therapy. Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med 2017;14:1403-1411.