Randomized Controlled Trial on Use of Letrozole in the Medical Management of Tubal Ectopic Pregnancies

UW 20-005

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.

2020-12-01

2024-12-30

2025-03-31

Recruiting

Early phase I

214

Inclusion Criteria: * Presence of heterogenous adnexal mass on USG suggestive of tubal ectopic pregnancy with hCG level \>=1500 IU/L and \<= 5000 IU/L * Absence of fetal heart pulsation * Mean diameter of adnexal mass \<= 3.5cm * Haemodynamically stable * No significant abdominal pain Exclusion Criteria: * Presence of significant amount of free fluid in pelvis * Allergic to MTX * Deranged liver function test (AST/ ALT or GGT \>= 2 upper limit of normal) * Deranged renal function test (eGFR \<= 45ml/min) * Heterotopic pregnancies

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into either receive letrozole or placebo capsules.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The identical looking placebo will be given. A computer generated sequence will be created. The sequence will be sealed in consecutively concealed opaque envelopes. Both the participant/ care provider/ investigator and outcomes assessor will blinded to the group assigned.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 214, 'type': 'ESTIMATED'}}

2023-04-10