| CTRI Number |
CTRI/2016/05/006951 [Registered on: 20/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
19/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effects of Cabergoline and Leuprolide acetate on pain in patients with endometriosis |
|
Scientific Title of Study
|
To Evaluate the Efficacy of Cabergoline as compared to GnRH Agonists in women with Endometriosis: A Prospective Open label Randomised Controlled Trial |
| Trial Acronym |
CAGE |
|
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 |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
E 28 West Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
E 28 West Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Jain |
| Designation |
Junior Resident |
| Affiliation |
AIIMS,New Delhi |
| Address |
R.No.3086,Department of Obstetrics and Gynaecology
3rd Floor,Teaching Block,
All India Institute of Medical Sciences
East Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9871038422 |
| Fax |
|
| Email |
neha.doctor.jain@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [] |
|
|
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 |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
R.no.3086,Department of Obstetrics and Gynaecology,
3rd floor,Teaching Block
EAST ANSARI NAGAR, NEW DELHI
South
DELHI |
9868246702
garimakachhawa2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Endometriosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cabergoline |
Cabergoline 0.5 mg tablet will be given twice weekly orally for 4 months |
| Comparator Agent |
Leuprolide acetate(GnRH agonists) |
Leuprolide acetate injection 3.75 mg will be given subcutaneously monthly for 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Women with a clinical diagnosis with endometriosis by previous laproscopy or USG.
2.Presence of ovarian endometrioma not more than 6cm in diameter.
3.Women do not want to conceive for next 6 months. |
|
| ExclusionCriteria |
| Details |
1.Patients with history of any hormonal treatment including contraceptives over past 3 months.
2.Body mass index (BMI) more than 30 kg/m2.
3.Patients with known history of allergy to one of the study medications.
4.Confirmed pregnancy.
5.H/o smoking, tobacco chewing.
6.Presence of hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease or any inflammatory disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in VAS score of pain more than 50% in these women.
2.Change in pre and post treatment levels of serum highly purified CRP(hpCRP),TNF-alpha and VEGF. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in size of Endometrioma as calculated by USG(more than 25% reduction will be taken as effective) |
4 months |
| Changes in Resistive Index (RI) and Pulsatility Index(PI) of ovarian blood flow. |
4 months |
| Changes in Pulse wave velocity of brachial artery |
4 months |
| Changes in the level of serum CA-125 and serum prolactin |
4 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2016 |
| Date of Study Completion (India) |
30/06/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2017 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective randomized, open label, parallel group, trial comparing the efficacy of Cabergoline 0.5mg tablet twice weekly and Leuprolide 3.75mg subcutaneous injections monthly for 4 months in 50 patients with endometriosis that will be conducted in Department of Obstetrics and Gynaecology, AIIMS. The primary outcome measures will be reduction in pain Visual Analog Score(VAS) by >50% and change in the pre and post treatment level of serum Vascular Endothelial Growth Factor(VEGF) after 4 months of treatment. The secondary outcomes will be reduction in size of endometrioma, changes in ovarian blood flow, change in pulse wave velocity of brachial artery and change in the serum levels of CA-125 and Prolactin after 4 months of treatment. Dosages: Cabergoline 0.5 mg twice weekly orally Leuprolide 3.75 mg monthly subcutaneously
Duration of treatment: 4 months |