Clinical trial · Interventional
Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
NCT01143584CI-TRIAL-00003566unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Macroprolactinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabergoline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rapid escalation
- description
- Weekly escalation of cabergoline dose in macroprolactinomas Start with 1 mg/week. increase by 1mg/wk every week till 4 weeks. after 4 weeks Cabergoline dose would be increased @1mg/wk every 4 weekly till normalization of prolactin and \>50% decrease in tumor volume from baseline.
- interventionNames
- Drug: cabergoline
- type
- ACTIVE_COMPARATOR
- label
- Conventional escalation
- description
- Conventional escalation of cabergoline In the Conventional escalation group schedule of cabergoline dosing will be 0.5 mg once a week for 4 weeks. Cabergoline will be incrementally dose adjusted on the basis of individual Prolactin values till amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or till primary endpoint.
- interventionNames
- Drug: Cabergoline
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Males or females presenting with 1. Prolactin secreting macroadenomas (≥10 mm maximum diameter) 2. With/without visual complaints 3. With /without parasellar or suprasellar extension 4. Treatment Naïve Exclusion Criteria: 1. On treatment with dopamine agonists. 2. Taking other drugs influencing prolactin Levels. 3. Systemic disease like Chronic Kidney Disease, Chronic Lung Disease 4. Other secondary causes of hyperprolactinemia. 5. Prolactin secreting microadenomas 6. Pregnancy during follow up 7. Prolactinoma as part of MEN-1 Syndrome 8. History suggestive of recent apoplexy (3 months) 9. Contraindication to cabergoline therapy like pre existing psychosis.
References
Publications (1)
- DERIVEDRastogi A, Bhansali A, Dutta P, Singh P, Vijaivergiya R, Gupta V, Sachdeva N, Bhadada SK, Walia R. A comparison between intensive and conventional cabergoline treatment of newly diagnosed patients with macroprolactinoma. Clin Endocrinol (Oxf). 2013 Sep;79(3):409-15. doi: 10.1111/cen.12149. Epub 2013 Jul 2. PMID 23347435