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临床试验/NCT02865187
NCT02865187已完成不适用

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

Wright State University2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年2月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Sexual Function

研究概览

简要总结

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.

详细描述

BACKGROUND:

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among reproductive age women with a prevalence as high as 15% using Rotterdam diagnostic criteria.1 PCOS is a heterogeneous clinical disorder characterized primarily by chronic anovulation and hyperandrogenism.2 A number of other metabolic and health complications are associated with PCOS including obesity, insulin resistance, dyslipidemia, type 2 diabetes, cardiovascular disease, and endometrial cancer.3

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 (HRQoL)4,5 including depression and anxiety,6,7 suicide attempts,8 body dissatisfaction,9 eating disorders,10 lower overall health-related quality of life11 and diminished sexual satisfaction.12,13

For women with PCOS, the changes in physical appearance and the associated mood disorders appear to be deleterious for sexual function.6 Previous research in this area is scant, and what has been done reveals a large number of women with PCOS (60%) reporting sexual dysfunction and that the domains of desire and arousal are most commonly affected (in 98% - 99% of cases). Using the Changes in Sexual Functioning Questionnaire (CSFQ), others have reported that women with PCOS were similar to control women in the number of sexual thoughts and fantasies and in the frequency of sexual intercourse, but differed significantly with lower orgasm/completion scores than control women.13 The existing research is limited by the study populations used, which have consisted of infertile women with PCOS who have a high prevalence of sexual dysfunction that may be more related to infertility and not an underlying sexual dysfunction, and by the possible impact of depression and psychotropic medications on sexual dysfunction.

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. Observational studies have shown that lower 25[OH]D levels are associated with insulin resistance, ovulatory and menstrual irregularities, lower pregnancy success, hirsutism, hyperandrogenism, obesity, and elevated cardiovascular disease risk factors14 as well as decreased HRQoL and depression in select populations.15 Nonetheless, there is limited research exploring the implications of vitamin D status and replacement on HRQoL issues including SDy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Reproductive age
  • 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
  • Report sexual dysfunction
  • Have no evidence of depression

排除标准

  • Has chronic medical illness such as diabetes mellitus, hypertension, and previous venous embolism
  • Taking any prescription medications for at least 3 months prior to entry into the study with the exception of allergy or occasional pain medications
  • Has other etiologies of anovulation and hyperandrogenism, e.g., Cushings disease, thyroid dysfunction, elevated prolactin levels, sighs of congenital adrenal hyperplasia
  • Has any contraindications to hormonal contraception

研究组 & 干预措施

Vitamin D + hormonal contraception

Experimental

600IU/day Vitamin D + hormonal contraception

干预措施: Vitamin D (Dietary Supplement)

Vitamin D + hormonal contraception

Experimental

600IU/day Vitamin D + hormonal contraception

干预措施: Hormonal contraception (Drug)

Vit D + non-hormonal contraception

Active Comparator

600IU/day Vitamin D

干预措施: Vitamin D (Dietary Supplement)

结局指标

主要结局

Sexual Function

时间窗: Month 6

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)

次要结局

  • Prevalence of Sexual Dysfunction in Women With PCOS(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Lindheim, MD

Professor, Director Reproductive Endocrinology and Infertility

Wright State University

研究点 (2)

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