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临床试验/NCT01977313
NCT01977313已完成不适用

Genetic Polymorphism of the Androgen Receptor-Gene and Sexual Function in Middle Aged Women

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
2 Subscores of the Female Sexual Function Index (FSFI): Satisfaction and Desire

研究概览

简要总结

It is known that with increasing age sexual desire is declining in women. Decreasing levels of androgens are believed to have an influence, but cannot explain the loss of libido completely. A possible explanation might be that the effect of the androgen is depending on the functionality of the androgen receptor. It is known that this functionality is genetically determined by the polymorphism of the androgen receptor gene. In the gene there is a varying number of CAG-repeats: the longer the CAG-Repeat, the lower the functionality of the androgen receptor, the lower the effect of the androgens. In this pilot study, the investigators would like to invite 45 healthy heterosexual middle-aged women to the University Hospital of Bern, where they answer questionnaires about their sexual function and where they give a blood sample to assess the testosterone serum levels and the genetically determined androgen receptor subtype.

The investigators believe that lower androgen levels and/or longer CAG-repeats in the androgen receptor gene are related to lower libido scores in healthy middle-aged women.

详细描述

Background

It is known that with increasing age sexual desire is declining in women. Multiple factors are being discussed to have an influence on this topic, such as cultural, individual and biological factors. Decreasing levels of sexual hormones and specifically androgens are believed to have an influence, hence a lot of women benefit from a testosterone replacement therapy. Yet the sole decline of androgen levels with inclining age cannot explain the loss of libido completely.

A possible further factor might be the androgen receptor: It is known that the effect of the androgen in its target cells is depending on the functionality of the androgen receptor. This functionality is genetically determined by the polymorphism of the androgen receptor gene: In the gene there is a sequence with a varying number of CAG-repeats. This CAG-repeat is coding for a polyglutamine stretch in the androgen receptor which is responsible for the binding of co-activator proteins. The better these co-activator proteins are bound to the androgen receptor, the better the transcriptional activity of the latter. Previous studies have shown that the longer the CAG-Repeat, the weaker the binding of co-activator proteins, the lower the functionality of the receptor and therefore the lower the effects of the androgen on the target cell. Given this circumstances the same level of androgen can have different effects in two individuals.

Objective

In this pilot study, the investigators would like to correlate the testosterone serum levels, the functionality of the androgen receptor and the libido in 45 healthy, heterosexual middle-aged women.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Heterosexual
  • Aged 45-65
  • Written Informed Consent
  • Living since at least 1 year in a relationship
  • Ready to answer questionnaires about their sexual function
  • Ready to give a blood sample
  • German speaking
  • Exclusion Criteria
  • Serious diseases such as Cancer, Parkinsons Disease, Multiple Sclerosis, Diabetes mellitus
  • Sexual Abuse in personal history
  • Thyroid dysfunction
  • Substance abuse (>1pack/cigarettes per day, alcohol, drugs)
  • Psychiatric diseases in personal history
  • Acute stressful life event
  • Libido affecting diseases such as dyspareunia, vaginism, orgasm disorders, urine incontinence
  • Medication with the following substances in the past 8 weeks before day of visit:
  • Systemic corticoids
  • Blood pressure medication with beta-blockers, spironolactone, thiazide diuretics
  • Psychotropic medication such as antidepressants, benzodiazepins, antiepileptics, antipsychotics (1st generation)
  • Opioid analgetics
  • Hormonal contraceptives
  • Libido stimulating medication such as androgens (Testosterone, Dehydroepiandrostendionsulfate, Dihydrotestosterone and PDE5-Inhibitants
  • Antiandrogens

排除标准

  • 未提供

结局指标

主要结局

2 Subscores of the Female Sexual Function Index (FSFI): Satisfaction and Desire

时间窗: 1 Day of visit

次要结局

  • Other 4 Subscores of the FSFI: Arousal, Lubrication, Orgasm and Pain(1 Day of visit)
  • CAG-repeats of the androgen receptor gene(1 Day of visit)
  • Testosterone serum levels(1 Day of visit)
  • Androgenity score(1 Day of visit)
  • Other influences on libido in middle aged women(1 Day of visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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