Sarebani Zinat, Alimoradi Zainab, Aali Ehsan, Mirzadeh Monirsadat, Chegini Venus, Abbaspour Mohammadreza, Griffiths Mark D
Students research committee, School of Nursing & Midwifery, Qazvin University of Medical Sciences, Qazvin, Iran.
Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Bahonar blv., Qazvin, 34197-59811, Iran.
BMC Womens Health. 2020 Feb 18;20(1):27. doi: 10.1186/s12905-020-00899-6.
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.
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.
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.
IRCT20180704040346N1 at 2018-10-13 prospectively registered.
更年期与性功能变化有关，部分原因是雌激素减少导致阴道萎缩。雌激素给药可暂时减轻阴道干燥症状，但长期使用该药物可能会引发严重并发症。鉴于先前关于维生素D对阴道干燥影响的研究取得了有前景的结果，本拟进行的研究将调查维生素D阴道栓剂对绝经后女性性功能的影响。
在一项随机对照临床试验中，105名绝经后女性将被随机分为三组，分别接受维生素D阴道栓剂、安慰剂阴道栓剂或对照组（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2周每晚使用，接下来的6周每隔一晚使用（共8周）。主要结局将是参与者的性功能，在干预前、干预后即刻以及干预结束后1个月和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 25版软件进行分析。若数据呈正态分布，将使用重复测量方差分析比较各组性功能的平均得分。若统计分析得出显著结果，将使用事后检验确定组间差异。将使用卡方检验和t检验等统计方法比较女性的人口统计学和生育特征。统计分析将采用p < 0.05的显著性水平。
如果维生素D阴道栓剂能改善绝经前女性的性功能且具有长期效果和最小副作用，那么该栓剂将被视为缓解该群体性功能障碍的一种安全的补充和替代选择。
于2018年10月13日在IRCT20180704040346N1进行前瞻性注册。
