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A clinical trial where participants will be divided into two groups, with drug intervention as Venlafaxine in one and placebo in other group and outcome will be analysed on basis of vasomotor symptoms.

Venlafaxine versus placebo for treatment of vaso-motor symptoms in gynaecological cancer survivors: A double-blind, randomized, placebo-controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079138
Enrollment
64
Registered
2025-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Velnafaxine: 37.5mg once daily orally for 12 weeks Control Intervention1: Placebo: 37.5 mg once daily orally for 12 weeks

Sponsors

AIIMS, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gynae cancer survivors who have received any form of treatment less than 2 years More than 18 years of age More than 14 hot flushes per week Completed treatment for gynaecological cancer Willing to participate and follow-up without discontinuation during the study period Life expectancy of more than 6month

Exclusion criteria

Exclusion criteria: Severe metabolic, thromboembolic or endocrine disease Uncontrolled hypertension Any major psychiatric condition that would confound evaluation Received previous treatment for hot flushes (eg. HRT)

Design outcomes

Primary

MeasureTime frame
Efficacy of Venlafaxine as compared to placebo on hot flashes in pre- menopausal gynae cancer survivors using 4 category Hot Flush DiaryTimepoint: 6weeks,12weeks and 2 weeks follow up

Secondary

MeasureTime frame
Quality of lifeTimepoint: 6weeks,12weeks and 2 weeks follow up;Side effectsTimepoint: 6weeks,12weeks and 2 weeks follow up;Depression and anxietyTimepoint: 6weeks,12weeks and 2 weeks follow up;Metabolic parametersTimepoint: 6weeks,12weeks and 2 weeks follow up

Countries

India

Contacts

Public ContactDr Nilanchali Singh

AIIMS, New Delhi

nilanchalisingh@gmail.com9811343168

Outcome results

None listed

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