Investigating the effect of vitamin D vaginal suppository on sexual function among postmenopausal women: study protocol for a randomized controlled trial

Abstract

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 longterm 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.

Effect of vitamin D vaginal suppository on sexual functioning among postmenopausal women: A three-arm randomized controlled clinical trial

“…Participants were postmenopausal women who were referred to comprehensive health service centers in Qazvin Province to receive postmenopausal care. The trial protocol has been peer-reviewed and published [ 23 ].…”

“…The methods of preparation and storage of the vitamin D and placebo suppositories were previously outlined in detail [ 23 ]. The vitamin D and placebo suppositories consisted of a common Suppocire AM-15 base and had the same shape, color, and weight.…”

Hypovitaminosis-D and sexual dysfunction

“…Numerous research has been conducted on vitamin D insufficiency and its effects on cardiovascular disease, multiple sclerosis and other neurological illnesses, depression, and metabolic syndrome. 7,8 reports of vitamin-D receptors in female reproductive organs such as the uterus and ovaries. An increased risk of obstetric and gynecologic issues, including endometriosis, polycystic ovaries, infertility, gestational diabetes, preeclampsia, and ovarian and breast cancer, is also linked to vitamin-D insufficiency.…”

Development and validation of the genitourinary syndrome of menopause symptoms and vaginal treatments acceptability questionnaire (GSM‐SVTAQ): An electronic patient‐reported outcomes measure

“…1,6,7 Increasing sexual activity and using vaginal lubricants and moisturizers are encouraged. 1 Vaginal vitamin D supplementation, [8][9][10][11] chamomile vaginal gel, 12 and vaginal vitamin E and hyaluronic acid suppositories have been investigated by a few studies. 13,14 Several international surveys have investigated the prevalence and perception of GSM symptoms in Europe, the USA, and Asia.…”

“…Increasing sexual activity and using vaginal lubricants and moisturizers are encouraged 1 . Vaginal vitamin D supplementation, 8–11 chamomile vaginal gel, 12 and vaginal vitamin E and hyaluronic acid suppositories have been investigated by a few studies 13,14 …”