Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner

ABSTRACT<i>Objective</i> The aim was to analyze the opinion of the male partner of women treated for vulvovaginal atrophy (VVA) with intravaginal 0.50% DHEA (prasterone), thus providing information on both members of the couple.<i>Methods</i> On a voluntary basis, in a prospective, randomized, double-blind and placebo-controlled phase-III clinical trial, the male partner filled a questionnaire at baseline and at 12 weeks stating his observations related to his penis and intercourse before and after VVA treatment.<i>Results</i> Sixty-six men having a partner treated with intravaginal DHEA and 34 others having a partner treated with placebo answered the questionnaires. Concerning the feeling of vaginal dryness of their female partner, the severity score following DHEA treatment improved by 81% (0.76 units) over placebo (<i>p</i> = 0.0347). Thirty-six percent of men having a partner treated with DHEA did not feel the vaginal dryness of the partner at the end of treatment compared to 7.8% in the placebo group. When analyzing the situation at 12 weeks compared to baseline, an improved score of 1.09 units was the difference found for the DHEA group compared to 0.76 for the placebo group (<i>p</i> = 0.05 vs. placebo). In the DHEA group, 38% of men scored very improved compared to 18% in the placebo group. No adverse event has been reported.<i>Conclusion</i> The male partner had a very positive evaluation of the treatment received by his female partner.

摘要

**研究目的**：本研究旨在分析接受阴道用0.50%脱氢表雄酮（DHEA，普拉睾酮，prasterone）治疗的外阴阴道萎缩（vulvovaginal atrophy, VVA）女性的男性伴侣的评价，从而为夫妻双方提供相关参考依据。

**研究方法**：本研究为一项前瞻性、随机、双盲、安慰剂对照的Ⅲ期临床试验，采用自愿参与模式。男性伴侣需在基线期及治疗12周时填写问卷，报告其自身阴茎相关状况以及伴侣接受VVA治疗前后的性交相关观察结果。

**研究结果**：共计66名女性伴侣接受阴道用DHEA治疗的男性，以及34名女性伴侣接受安慰剂治疗的男性完成了问卷回收。针对伴侣的阴道干涩症状，与安慰剂组相比，DHEA治疗组的严重程度评分改善幅度达81%（差值为0.76分，p=0.0347）。治疗结束时，36%的DHEA组男性表示未察觉到伴侣的阴道干涩症状，而安慰剂组该比例仅为7.8%。与基线期相比，治疗12周时DHEA组的评分改善幅度为1.09分，安慰剂组为0.76分（与安慰剂组相比，p=0.05）。DHEA组中38%的男性给出了"显著改善"的评价，安慰剂组该比例为18%。本研究未报告任何不良事件。

**研究结论**：男性伴侣对其女性伴侣所接受的治疗给出了极为积极的评价。