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Clinical Trials/CTRI/2025/03/083339
CTRI/2025/03/083339Not yet recruitingNot Applicable

Estimation of androgen levels and body mass index in hirsutism

Indian Association of Dermatologists Venereologists and Leprologists Karnataka1 site in 1 country71 target enrollmentStarted: April 24, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
71
Locations
1
Primary Endpoint
To estimate the androgen levels in patients with hirsutism and to find the association between BMI, androgen levels and the severity of hirsutism.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
15.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Indian Association of Dermatologists Venereologists and Leprologists Karnataka
Sponsor Class
Other [Association of dermatologists]
Responsible Party
Principal Investigator
Principal Investigator

Divya Madonna Dsouza

Private healthcare

Study Sites (1)

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