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临床试验/CTRI/2025/03/083339
CTRI/2025/03/083339尚未招募不适用

Estimation of androgen levels and body mass index in hirsutism

Indian Association of Dermatologists Venereologists and Leprologists Karnataka1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2025年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
71
试验地点
1
主要终点
To estimate the androgen levels in patients with hirsutism and to find the association between BMI, androgen levels and the severity of hirsutism.

研究概览

简要总结

Hirsutism is defined as the presence of excessive coarse terminal hairs in females in a male-like distribution affecting around 5-10% of women. Hirsutism is a frequent reason of cosmetic embarrassment, poor self esteem, and psychological distress for women world over. Although more than 95% of the women with hirsutism have a relatively benign condition like idiopathic hirsutism or polycystic ovary syndrome (PCOS), more sinister causes like congenital adrenal hyperplasia, Cushing’s syndrome, and benign and malignant androgen-secreting adrenal or ovarian tumors may underlie hirsutism. Hence it is necessary to endocrinologically evaluate patients with hirsutism.
The incidence of PCOS and obesity has increased over the recent years. This is due to sedentary lifestyle, stress and high glycemic index diet. Obesity in females is usually associated with hyperandrogenemia. Hirsutism is often the initial, and possibly only sign of an underlying androgen disorder. There are few studies which have assessed both Body mass index (BMI) and androgen levels in women with hirsutism of reproductive age group in the Indian population. The present work is undertaken to explore the effects of BMI on serum androgen parameters in hirsute women of reproductive years. This study is done to estimate the levels of total testosterone, Dehydroepiandrosterone sulfate (DHEAS), Sex hormone binding globulin (SHBG), 17-Hydroxyprogesterone and to measure the BMI, Free Androgen Index (FAI) in hirsutism.

AIM OF THE STUDY :

i.         To estimate the androgen levels in patients with hirsutism and to find the association between BMI, androgen levels and the severity of hirsutism.
Objectives of the study :

1.To study the clinical characteristics of patients presenting with hirsutism

  1. To assess the androgen levels such as serum total testosterone, sex hormone binding globulin, serum DHEAS, serum 17 hydroxy progesterone, Free androgen index in hirsutism and  to find the association between BMI, androgen levels and the severity of hirsutism

Implications of the study:

i.         With this study, we may be able to find an association between the various androgen parameters with Body mass index in hirsutism.

ii.          The knowledge derived from this study can help us know the benefits of weight reduction and lifestyle modifications in management of Hirsutism

.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Women who are postmenarchal
  • All cases clinically diagnosed cases with Hirsutism who are willing to participate in the study .

排除标准

  • Women with Hirsutism who have been on oral hormonal treatment, anti-androgens, or insulin sensitizers.
  • Pregnant and lactating women.
  • Women who have attained menopause
  • Patients on medications which cause hirsutism such as androgen therapy (testosterone), Danazol, androgenic progestins (levonorgestrel, norethindrone and norgestrel), glucocorticoids, phenytoin, minoxidil, sodium valproate, cyclosporine.

结局指标

主要结局

To estimate the androgen levels in patients with hirsutism and to find the association between BMI, androgen levels and the severity of hirsutism.

时间窗: 1 year

次要结局

  • i. To study the clinical characteristics of patients presenting with hirsutism(ii. To assess the androgen levels such as serum total testosterone, sex hormone binding globulin, serum DHEAS, serum 17 hydroxy progesterone, Free androgen index in hirsutism and to find the association between BMI, androgen levels and the severity of hirsutism.)

研究者

发起方
Indian Association of Dermatologists Venereologists and Leprologists Karnataka
申办方类型
Other [Association of dermatologists]
责任方
Principal Investigator
主要研究者

Divya Madonna Dsouza

Private healthcare

研究点 (1)

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