| CTRI Number |
CTRI/2025/03/083339 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between obesity and androgen levels in hirsutism |
|
Scientific Title of Study
|
Estimation of androgen levels and body mass index in hirsutism |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Madonna Dsouza |
| Designation |
Post graduate resident |
| Affiliation |
Private healthcare |
| Address |
Department of dermatology, venereology and leprosy,
Father Muller Medical College, Kankanady, Mangalore
Divya Sadan, Karavali lane, Nanthoor, Mangalore-575 002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
917996190879 |
| Fax |
|
| Email |
divyamadonnadsouza@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jacintha Martis |
| Designation |
Head of the department and Professor |
| Affiliation |
Private healthcare |
| Address |
Department of Dermatology, Venereology and Leprosy,
Father Muller Medical College, Kankanady, Mangalore
Father Muller road, Kankanady, Mangalore-575 002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
dr_martisj@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Divya Madonna Dsouza |
| Designation |
Post graduate resident |
| Affiliation |
Private healthcare |
| Address |
Department of dermatology, venereology and leprosy,
Father Muller Medical College, Kankanady, Mangalore
Divya Sadan, Karavali lane, Nanthoor, Mangalore-575 002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
917996190879 |
| Fax |
|
| Email |
divyamadonnadsouza@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College, Kankanady, Mangalore-575 002, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Indian Association of Dermatologists Venereologists and Leprologists Karnataka |
| Address |
No.5/1, 3rd Floor, 4th Main, MRCR Layout, Vijayanagara, Bengaluru, Karnataka. 560040 |
| Type of Sponsor |
Other [Association of dermatologists] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Madonna Dsouza |
Father Muller Medical College |
OPD Number 65,Dermatology outpatient department, Father Muller road, Kankanady-575 002
Dakshina Kannada
KARNATAKA |
917996190879
divyamadonnadsouza@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, (2) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Women who are postmenarchal
2. All cases clinically diagnosed cases with Hirsutism who are willing to participate in the study .
|
|
| ExclusionCriteria |
| Details |
1. Women with Hirsutism who have been on oral hormonal treatment, anti-androgens, or insulin sensitizers.
2. Pregnant and lactating women.
3. Women who have attained menopause
4. Patients on medications which cause hirsutism such as androgen therapy (testosterone), Danazol, androgenic progestins (levonorgestrel, norethindrone and norgestrel), glucocorticoids, phenytoin, minoxidil, sodium valproate, cyclosporine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the androgen levels in patients with hirsutism and to find the association between BMI, androgen levels and the severity of hirsutism. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="71"
Sample Size from India="71"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 2. 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 |
| . | | |