To compare the effects of Cabergoline and Leuprolide acetate on pain in patients with endometriosis

Completed

• Conditions: Endometriosis

• Registration Number: CTRI/2016/05/006951
• Lead Sponsor: Not Applicable

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-19
• Last Update Posted: 2016-05-19
• Study Completion: 2017-06-30

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in VAS score of pain more than 50% in these women.	4 months
2.Change in pre and post treatment levels of serum highly purified CRP(hpCRP),TNF-alpha and VEGF.	4 months

Secondary Outcome Measures

Name	Time	Method
Changes in Resistive Index (RI) and Pulsatility Index(PI) of ovarian blood flow.	4 months
Reduction in size of Endometrioma as calculated by USG(more than 25% reduction will be taken as effective)	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

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES; 🇮🇳 South, DELHI, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

🇮🇳South, DELHI, India

Dr Garima Kachhawa

Principal investigator

9868246702

garimakachhawa2012@gmail.com