Mifepristone and Letrozole in Ectopic Pregnancy (MILE)
- Conditions
- Ectopic pregnancyTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2023-503935-16-00
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 316
Confirmed ectopic pregnancy, or high suspicion thereof*, in need of treatment. *i.e. empty uterus, pathological hCG dynamic., 18 years old or above, Able to understand verbal and written patient information, Given written consent to participate in the trial
hCG-levels >5000 IU/L, Heterogenous adnexal mass >35mm, Fetal heart pulsation, Signs of rupture such as large amount of free fluid in the abdomen, severe abdominal pain or hemodynamically unstable, Heterotopic or atypical (cesarean scar pregnancy, cornual, intramural, cervical or abdominal pregnancy) extrauterine pregnancy, Contraindications* to methotrexate, letrozole or mifepristone. * Allergy, severe liver disease (ALT/AST doubled, kidney disease (GFR <60ml/min), bone marrow suppression, active ulcer, severe stomatitis, breastfeeding, severe infection, chronic adrenal insufficiency, porphyria, uncontrolled asthma, active cancer treatment, ongoing treatment for psychosis, anticoagulants, high alcohol consumption
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method