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NCT02865187 · ClinicalTrials.gov registry record · NA
Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction
A NA study of Polycystic Ovary Syndrome and Female Sexual Dysfunction, sponsored by Wright State University.
- Completed
- Registry status
- NA
- Development phase
- 47
- Enrollment target
- 2
- Study locations
NCT02865187 is a NA study of Polycystic Ovary Syndrome and Female Sexual Dysfunction that has completed, run by Wright State University. The registered enrollment target is 47 participants, below the 17,256-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT02865187, a NA study of Polycystic Ovary Syndrome and Female Sexual Dysfunction, has completed, sponsored by Wright State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
- 2
- Study locations
Study 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 Depress
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- DRUG Hormonal contraception
Study Locations (2)
Ohio
- Wright State Physicians - Dayton
Pennsylvania
- Pennsylvania State University - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2020-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02865187
The ClinicalTrials.gov registry entry for NCT02865187 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 17,256-participant average among 30 other Polycystic Ovary Syndrome trials with a reported enrollment target (100% lower). The listed sponsor is Wright State University, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Polycystic Ovary Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Vitamin D is the first listed.
NCT02865187 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02865187 about?
NCT02865187 is a clinical study titled "Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction". 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 cardi...
What is the current status of trial NCT02865187?
This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2017-02-06. Estimated completion is 2020-12-31.
What conditions does trial NCT02865187 study?
This clinical trial studies the following conditions: Polycystic Ovary Syndrome, Female Sexual Dysfunction.
What interventions are being tested in trial NCT02865187?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Hormonal contraception (DRUG).
Who is sponsoring clinical trial NCT02865187?
This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02865187 being conducted?
This trial has 2 study locations across Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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