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

To Evaluate the Efficacy of Cabergoline as compared to GnRH Agonists in women with Endometriosis: A Prospective Open label Randomised Controlled Trial - CAGE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006951
Enrollment
50
Registered
2016-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Endometriosis

Interventions

Intervention1: Cabergoline: Cabergoline 0.5 mg tablet will be given twice weekly orally for 4 months Control Intervention1: Leuprolide acetate(GnRH agonists): Leuprolide acetate injection 3.75 mg will

Sponsors

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 4 months

Secondary

MeasureTime frame
Changes in Pulse wave velocity of brachial arteryTimepoint: 4 months;Changes in Resistive Index (RI) and Pulsatility Index(PI) of ovarian blood flow.Timepoint: 4 months;Changes in the level of serum CA-125 and serum prolactinTimepoint: 4 months;Reduction in size of Endometrioma as calculated by USG(more than 25% reduction will be taken as effective)Timepoint: 4 months

Countries

India

Contacts

Public ContactDr Neha Jain

AIIMS, New Delhi

garimakachhawa2012@gmail.com9868246702

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026