BACKGROUND Menopause is associated with changes in sexual function which are partly due to vaginal atrophy in response to estrogen reduction. Estrogen administration temporarily reduces the symptoms of vaginal dryness, but long-term exposure to this drug is likely to be associated with serious complications. Considering the promising results of previous studies concerning the effect of vitamin D on vaginal dryness, the proposed study will investigate the effect of vitamin D vaginal suppository on the sexual function of postmenopausal women. METHODS In a randomized, controlled clinical trial, 105 postmenopausal women will be randomly assigned to three groups receiving vitamin D vaginal suppository, placebo vaginal suppository, or control (no intervention). Vitamin D vaginal suppositories contain 1000 units of vitamin D3. The timing of the use of vitamin D vaginal suppositories and placebo suppositories will be every night in the first 2 weeks, and every other night in the following 6 weeks (8 weeks in total). The primary outcome will be the sexual function of participants which will be assessed using the Female Sexual Function Index (FSFI) before and immediately after the intervention, and at 1 and 2 months after the end of the intervention. The side effects of these suppositories will be examined as a secondary consequence of the study. Data will be analyzed using SPSS software version 25. In the case of normal distribution of data, the mean score of sexual function will be compared between the groups using a repeated measurements ANOVA. If statistical analysis leads to significant results, the post-hoc test will be used to determine the differences between the groups. Comparison of demographic and fertility characteristics of the women will be carried out using statistical tests such as chi-squares and t-tests. A significance level of p < .05 will be used for statistical analyses. DISCUSSION If vitamin D vaginal suppositories improve sexual function among premenopausal women with long-term effects and minimum side effects, the suppositories will be considered a safe complementary and alternative choice for alleviating sexual dysfunction among this group. TRIAL REGISTRATION IRCT20180704040346N1 at 2018-10-13 prospectively registered.

中文翻译：

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研究维生素D阴道栓对绝经后妇女性功能的影响：一项随机对照试验的研究方案。

背景技术更年期与性功能改变有关，这部分是由于雌激素减少引起的阴道萎缩。服用雌激素可以暂时减轻阴道干燥的症状，但是长期接触这种药物很可能会引起严重的并发症。考虑到以前有关维生素D对阴道干燥的影响的研究的有希望的结果，拟议的研究将调查维生素D阴道栓对绝经后妇女性功能的影响。方法在一项随机对照临床试验中，将105名绝经后妇女随机分为三组，分别接受维生素D阴道栓，安慰剂阴道栓或对照组（无干预）。维生素D阴道栓剂含有1000单位的维生素D3。维生素D阴道栓剂和安慰剂栓剂的使用时间为前两个星期的每晚，以及随后六个星期的另一个夜晚（总共8个星期）。主要结果将是参与者的性功能，将在干预之前和之后以及干预结束后1和2个月使用女性性功能指数（FSFI）进行评估。这些栓剂的副作用将作为研究的次要结果进行检查。数据将使用SPSS软件版本25进行分析。在数据呈正态分布的情况下，将使用重复测量方差分析比较两组之间的性功能平均得分。如果统计分析得出显著结果，事后测试将用于确定组之间的差异。将使用统计检验（例如卡方检验和t检验）对妇女的人口统计学特征和生育力特征进行比较。p <.05的显着性水平将用于统计分析。讨论如果维生素D阴道栓剂能改善绝经前妇女的性功能，并具有长期效果和最小的副作用，则该栓剂将被视为缓解该组性功能障碍的安全补充和替代选择。试用注册IRCT20180704040346N1于2018-10-13进行了预先注册。05将用于统计分析。讨论如果维生素D阴道栓剂能改善绝经前妇女的性功能，并具有长期效果和最小的副作用，则该栓剂将被视为缓解该组性功能障碍的安全补充和替代选择。试用注册IRCT20180704040346N1于2018-10-13进行了预先注册。05将用于统计分析。讨论如果维生素D阴道栓剂能改善绝经前妇女的性功能，并具有长期效果和最小的副作用，则该栓剂将被视为缓解该组性功能障碍的安全补充和替代选择。试用注册IRCT20180704040346N1于2018-10-13进行了预先注册。