| CTRI Number |
CTRI/2024/08/071776 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the benefits of addition of Cabergoline to Metformin in women with PCOS |
|
Scientific Title of Study
|
To study the efficacy of Cabergoline as an adjunct to Metformin in management
of overweight & obese women with PCOS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Kachhawa |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room Number 701, 7th Floor,
Department of Obstetrics & Gynaecology, Mother and Child Block, Gate Number 6B, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room Number 701, 7th Floor, Department of Obstetrics & Gynaecology, Mother and Child Block, Gate Number 6B, AIIMS New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
911126588641 |
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Choudhary |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
C/O Professor Garima Kachhawa
Room Number 701, 7th Floor, Department of Obstetrics & Gynaecology, Mother and Child Block, Gate Number 6B, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9511533570 |
| Fax |
|
| Email |
cmamta309@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Garima Kachhawa |
AIIMS, New Delhi |
Room Number - 701, 7th Floor, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI |
9868246702
911126588641
garimakachhawa2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Cabergoline with Tablet Metformin |
Tablet Cabergoline 0.5 mg once a week with Tablet Metformin 850 mg twice a day for 6 months |
| Comparator Agent |
Tablet Metformin |
850 mg twice a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with PCOS by Rotterdam
criteria, Age 16-35 years, BMI 23-35 kg/m2, Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with other endocrine disorders such as
Cushing’s Syndrome, acromegaly, pituitary
adenoma, etc , Women planning pregnancy in next 6 months, Intolerability to cabergoline, Not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regularization of menses |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in serum inflammatory markers |
1, 3, 6 months |
| Improvement in glycemic parameter |
1, 3, 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/08/2024 |
| 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
|
Women with PCOS have menstrual irregularities, hyperandrogenism and elevated level of inflammatory markers such as CRP , interleukins (IL-6, 18) TNF alpha, WBC count, chronic inflammatory state is further exacerbated by factors such as obesity and hyperinsulinemia, elevated level of inflammatory markers and oxidative stress indicate endothelial cell damage , Metformin alone is not as effective as in combination with other insulin sensitizer in improving glycolipid parameters in obese PCOS, Cabergoline an antiangiogenic reduces inflammatory markers in patients with prolactinoma and endometriosis. Cabergoline improves insulin sensitivity, leads to weight reduction and normalizing menstrual irregularities and androgen level in PCOS patients. We aim to evaluate the effect of add on Cabergoline with standard metformin on hormonal profile and menstrual regulation in women with overweight/obese PCOS. |