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Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction
NA trial testing Vitamin D in Female Sexual Dysfunction in 47 participants. Completed in 31 December 2020.
| Lead sponsor | Wright State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 6 February 2017 |
| Primary completion | 31 March 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 2 locations across United States |
Wright State University
Adults 18 to 40, female only, with Female Sexual Dysfunction or Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Female Sexual Function Index (FSFI) scores at Month 6 (Total score ranges from 2 - 36; scores less than 26.55 represent presence/degree of sexual dysfunction)
| Group | Value | 95% CI |
|---|---|---|
| Vitamin D + Hormonal Contraception | 24.8 | ± 7.6 |
| Vit D + Non-hormonal Contraception | 26.0 | ± 4.7 |
Prevalence rate of women with PCOS defined by scores of the FSFI (total scores range from 2-36; scores less than 26.55 represent presence/degree of sexual dysfunction) - For this outcome, total scores were converted, using the cutoff score of 26.55, into a dichotomous variable for presence or absence of sexual dysfunction.
| Group | Value | 95% CI |
|---|---|---|
| Vitamin D + Hormonal Contraception | 26 | |
| Vit D + Non-hormonal Contraception | 11 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Vitamin D + Hormonal Contr… | Vit D + Non-hormonal Contr… |
|---|---|---|---|
| worsening depression | Psychiatric disorders | — | — |
Data from ClinicalTrials.gov NCT02865187 adverse events section.
SUMMARY: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among reproductive age women with a prevalence as high as 15%. The clinical symptoms of PCOS including menstrual dysfunction, infertility, hirsutism, alopecia, acne, and the possible increased risk of diabetes and cardiovascular disease have been reported to be significant contributors to psychological morbidity and impact health-related quality of life. For women with PCOS, the changes in physical appearance and the associated mood disorders appear to be deleterious for sexual function. Vitamin D deficiency (\<20 ng/ml serum concentration of 25\[OH\]D), which affects from 67% to 85% of women,4 is closely linked to symptoms of PCOS. The main physiologic role of vitamin D is to regulate calcium and phosphorus homeostasis and to promote bone health. Although there has been an increase in awareness of the importance of sexual dysfunction and QoL in women with PCOS, few studies have evaluated the outcomes of treatment for PCOS upon sexual and subjective health status of women. The goals of this study are: 1. To evaluate the prevalence of sexual dysfunction (SDy) in women with Polycystic Ovarian Syndrome (PCOS) 2. To determine the effects of Vitamin D therapy, with and without hormonal contraceptives, on SDy in women with PCOS in the absence of depression. METHODS: The study will enroll 60 women diagnosed with PCOS and reporting SDy at the Wright State Physicians (WSP) OB-GYN Practice and the WSP Family Medicine Practice. All participants will take vitamin D 600IU/day and will choose between hormonal and non-hormonal contraceptive methods (target of 30 participants in each group). Participants will complete three study visits (Initial, Month 3, and Month 6). Vitamin D levels will be drawn at the beginning of the study and again at 3 and 6 months after initiation of vitamin D therapy. Each participant will be asked to complete the Female Sexual Function Index (FSFI) and the Beck Depression Inventory (BDI) prior to initiation of treatment and again at 6 months.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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