CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Hormonal contraception +1 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02865187
NCT02865187N/ACompleted

Evaluation of Vitamin D With and Without Hormonal Contraception on Sexual Function in Women With Polycystic Ovary Syndrome

Wright State University·interventional·Posted Aug 12, 2016·Updated Mar 25, 2022

In Brief

A clinical study evaluating Vitamin D and Hormonal contraception for Female Sexual Dysfunction and Polycystic Ovary Syndrome. Completed, enrolled 47 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 12, 2016
Enrollment StartFeb 6, 2017
Primary CompletionMar 31, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.9 years ago

Interventions

Vitamin Ddietary

Vitamin D 600IU/day

Hormonal contraceptiondrug

Hormonal contraceptives