interventional
N/A
6 countries
10
To evaluate if the combination of mifepristone and letrozole is non-inferior to methotrexate in treating ectopic pregnancy within a non-inferiority margin of 10%.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2023
Actual (reported)The primary endpoint is the proportion of patients who have a successful treatment response defined as decline of serum hCG to < 2 IU/L without the need for any additional medical or surgical intervention within 60 days of treatment.
The proportion of patients in both groups with adverse events (AE) and serious adverse events (SAE) classified as related or possibly related to treatment as judged by the investigators.
The proportion of patients who need additional medical or surgical interventions in each group.
Time to resolution (days) of ectopic pregnancy from start of medical treatment to resolution defined as hCG <2 IU/L.
AMH-levels at baseline, 1 month and 3 months after treatment. We will also assess time to pregnancy (days) and pregnancy rates (%) within the first year after treatment.
Micro RNAs (analyzed by single cell sequencing) profiles and CA-125 (patients receiving treatment for ectopic pregnancy versus patients with ultrasound confirmed intrauterine pregnancy within the same period of gestation).
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Mifegyne 200 mg tabletter
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
Letrozole Sandoz 2,5 mg filmdragerade tabletter
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Mifegyne 200 mg tabletter
Named ingredient: Mifepristone
View registry recordLetrozole Sandoz 2,5 mg filmdragerade tabletter
Named ingredient: Letrozole
View registry recordSoedersjukhuset AB
Stockholm, 118 61, Sweden
Region Vaesterbotten
Umea, 907 37, Sweden
Region Oerebro Laen
Orebro, 701 85, Sweden
Kristina Cederblad
First Submitted
May 4, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Contact the study team to confirm eligibility.
Uppsala University Hospital
Uppsala, 751 85, Sweden
Karolinska University Hospital
Huddinge, 141 86, Sweden
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Goteborg, 413 46, Sweden
Aalborg University Hospital
Gistrup, 9260, Denmark
Hospital Sønderjylland
Aabenraa, 6200, Denmark
HUS-yhtymae
Helsinki, 00029, Finland
Rigas Austrumu kliniska universitates slimnica SIA
Riga, LV-1079, Latvia