N/A
N=47
Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction
Female Sexual Dysfunction · Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02865187 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Sexual Function — 24.8; 26.0 score on a scale — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D (Dietary_supplement); Hormonal contraception (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wright State University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sexual Function |
24.8; 26.0 | 0.71 |
| SECONDARY Prevalence of Sexual Dysfunction in Women With PCOS |
26; 11 | 1.00 |
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.
Eligibility Criteria
Inclusion Criteria
- 1. Reproductive age
- 2. Have diagnosis of polycystic ovary syndrome by Rotterdam criteria (at least 2 of 3 criteria):
- a. Oligomenorrhea (cycles lasting > 35 days) or amenorrhea (< 3 cycles in last 6 months)
- b. Clinical signs of hyperandrogenism or elevated total testosterone level
- c. Polycystic appearing ovaries
- 3. Report sexual dysfunction
- 4. Have no evidence of depression
Exclusion Criteria
- 1. Has chronic medical illness such as diabetes mellitus, hypertension, and previous venous embolism
- 2. Taking any prescription medications for at least 3 months prior to entry into the study with the exception of allergy or occasional pain medications
- 3. Has other etiologies of anovulation and hyperandrogenism, e.g., Cushings disease, thyroid dysfunction, elevated prolactin levels, sighs of congenital adrenal hyperplasia
- 4. Has any contraindications to hormonal contraception
Data sourced from ClinicalTrials.gov (NCT02865187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.