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Clinical trial

Management of Tubal Pregnancy With Off-label Use of Letrozole in Monotherapy

ID
Name
1072.6120.321.2020
Description
It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (MTX) in women refusing surgery. The aim was to compare the effectiveness of letrozole with MTX in the management of tubal pregnancy.
Trial arms
Trial start
2020-12-01
Estimated PCD
2022-12-30
Trial end
2023-06-30
Status
Completed
Treatment
Letrozole as monotherapy
Letrozole 5 mg daily orally for 10 days from day 0
Arms:
Tubal pregnancy treated with letrozole
MTX as monotherapy
MTX in a single dose of 100 mg intravenously on day 0
Arms:
Tubal pregnancy treated with MTX
Size
22
Primary endpoint
The effectiveness of the treatment
up to 6 months
Eligibility criteria
Inclusion Criteria: * tubal pregnancy confirmed on pelvic ultrasound * increasing serum B-hCG concentrations in at least two subsequent measures * serum B-hCG concentration ≤ 3000 mIU/ml Exclusion Criteria: * free fluid in lesser pelvis on pelvic ultrasound * positive fetal heartbeat on pelvic ultrasound * abdominal pain * heterotopic pregnancy * contraindications to MTX
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

2 products

1 indication

Organization
Jagiellonian University
Product
Letrozole
Indication
Tubal Pregnancy
Product
MTX