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RCT on the Efficacy of Methotrexate for the Prevention of GTD

NCT01984099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2020-04-17

No results posted yet for this study

Summary

A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.

Conditions

  • Hydatidiform Mole

Interventions

DRUG

Methotrexate

Patients will be given a single course of methotrexate within fourteen days from molar evacuation.

DRUG

Vitamin B Complex

Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.

Sponsors & Collaborators

  • University of the Philippines

    lead OTHER

Principal Investigators

  • Agnes L. Soriano-Estrella, MD · University of the Philippines Manila

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Philippines

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984099 on ClinicalTrials.gov