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Letrozole in Tubal Ectopic Pregnancy

NCT04341545 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2023-04-10

No results posted yet for this study

Summary

This is a multi-centred randomized controlled trial on the addition of letrozole in the medical management of tubal ectopic pregnancies.

Tubal ectopic pregnancies are abnormal pregnancies in the Fallopian tube, rather than in the womb. They occurred in around 1-2% of all pregnancies. Methotrexate (MTX) given by the intramuscular route i.e. systemic, a commonly used drug for cancer , was a widely used alternative for management for unruptured tubal ectopic pregnancies and was recommended as first line treatment for selected women.

Letrozole, aromatase inhibitor, can suppose oestradiol level. Combination of letrozole with misprostol has shown to improve the complete abortion rate in miscarriage. As a result, addition of letrozole may cause a higher success rate in the medical treatment of ectopic pregnancy.

As the evidence of combination of MTX and letrozole in tubal ectopic pregnancies is not available, the objective of the present study is to evaluate the efficacy of combination of MTX and letrozole compared to MTX alone in women with tubal ectopic pregnancies.

Conditions

  • Tubal Pregnancy

Interventions

OTHER

Placebos

Placebo 4 tablets a day for one week.

DRUG

Letrozole tablets

Letrozole 10mg daily for one week.

Sponsors & Collaborators

  • Kwong Wah Hospital

    collaborator OTHER

  • Princess Margaret Hospital, Hong Kong

    collaborator OTHER_GOV

  • Pamela Youde Nethersole Eastern Hospital, Hong Kong

    collaborator UNKNOWN

  • Queen Elizabeth Hospital, Hong Kong

    collaborator OTHER

  • Prince of Wales Hospital, Shatin, Hong Kong

    collaborator OTHER

  • Queen Mary Hospital, Hong Kong

    lead OTHER

Principal Investigators

  • Ernest H.Y. Ng, MD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-12-30
Completion
2025-03-31

Countries

  • Hong Kong

Study Locations

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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 NCT04341545 on ClinicalTrials.gov