Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction
Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Wright State University
Collaborator:
Patty Brisben Foundation For Women's Sexual Health