Study on Mifepristone and Letrozole for Treating Ectopic Pregnancy in Comparison to Methotrexate

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What is this study about?

This clinical trial is focused on studying the treatment of ectopic pregnancy, a condition where a fertilized egg implants outside the uterus, often in a fallopian tube. The study will compare two treatment options: a combination of the medications mifepristone and letrozole, and the medication methotrexate. Mifepristone, also known by its code name RU-486, is typically used to terminate early pregnancies, while letrozole is often used in breast cancer treatment. Methotrexate is a medication that can treat certain types of cancer and autoimmune diseases, and it is also used to treat ectopic pregnancies.

The purpose of this study is to determine if the combination of mifepristone and letrozole is as effective as methotrexate in treating ectopic pregnancy. Participants in the study will be randomly assigned to receive either the combination of mifepristone and letrozole or methotrexate. The study will monitor the participants over a period to see how well the treatments work in resolving the ectopic pregnancy without the need for additional medical or surgical intervention.

Throughout the study, researchers will also observe any side effects or adverse events related to the treatments. The study aims to provide valuable information on the effectiveness and safety of these treatment options for ectopic pregnancy, potentially offering new insights into managing this condition. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 initial visit and consent

Upon joining the study, the first step involves an initial visit where the condition of ectopic pregnancy is confirmed or highly suspected. This is determined by an empty uterus and specific hormone levels.

Participants must be at least 18 years old and able to understand the provided information. Written consent is required to proceed with the trial.

2 randomization and treatment assignment

Participants are randomly assigned to one of two treatment groups. One group receives a combination of mifepristone and letrozole, while the other group receives methotrexate.

The purpose is to evaluate if the combination of mifepristone and letrozole is as effective as methotrexate in treating ectopic pregnancy.

3 treatment administration

For those receiving methotrexate, the medication is administered as an intramuscular injection. The dosage and frequency are determined by the study protocol.

Participants in the mifepristone and letrozole group take these medications orally. The specific dosage and frequency are provided by the study team.

4 monitoring and follow-up

Participants are monitored regularly to assess the treatment’s effectiveness. This includes measuring hormone levels to ensure they decrease to the desired level.

Follow-up visits occur over a period of up to 60 days to check for successful treatment response and to monitor for any side effects or adverse events.

5 evaluation of treatment success

The primary goal is to achieve a successful treatment response, defined as a decrease in hormone levels to below a specific threshold without needing additional medical or surgical intervention.

Secondary evaluations include monitoring for any adverse events, the need for further interventions, and the time taken for the ectopic pregnancy to resolve.

6 long-term follow-up

Participants may be asked to attend follow-up appointments at 1 month and 3 months after treatment to assess hormone levels and other health indicators.

Additional assessments may include time to future pregnancy and pregnancy rates within the first year after treatment.

Who Can Join the Study?

Confirmed ectopic pregnancy, or a high suspicion of it, which means the pregnancy is outside the uterus and needs treatment. This can be indicated by an empty uterus or unusual levels of a pregnancy hormone called hCG.
Must be 18 years old or older.
Able to understand both spoken and written information about the study.
Must have given written consent to participate in the study.

Who Cannot Join the Study?

Participants must not have any other medical conditions that could interfere with the study.
Participants should not be pregnant with a normal pregnancy, as the study focuses on ectopic pregnancy, which is a pregnancy that occurs outside the uterus.
Participants must not be male, as the study is only for females.
Participants should not be part of a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Ucoofvc Ubeytahiqf Hlehnmri	Uppsala	Sweden
Stzcyhvghok Ucjfwtdmms Hcidcwqasqbhnyf Gbgjgixxlzzbrtfro	Gothenburg	Sweden
Ryuwc Atobitxy koabzmax ukloyzsaoncof stmflfcl Siv	Riga	Latvia

Trial status

Country	Status	Recruitment Start
Latvia	Not yet recruiting	01.09.2023
Sweden	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Mifepristone is a medication that is often used to end early pregnancies. In this trial, it is being tested to see if it can help treat ectopic pregnancies, which occur when a fertilized egg implants outside the uterus. Mifepristone works by blocking the hormone progesterone, which is necessary for pregnancy to continue. By doing this, it helps stop the growth of the pregnancy tissue.

Letrozole is a medication that is usually used to treat breast cancer in postmenopausal women. It works by lowering estrogen levels in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow. In this trial, letrozole is being used in combination with mifepristone to see if it can effectively treat ectopic pregnancies.

Methotrexate is a medication that is commonly used to treat certain types of cancer and autoimmune diseases. It works by slowing down the growth of cells, including those of the pregnancy tissue in an ectopic pregnancy. In this trial, methotrexate is being used as a comparison to see if the combination of mifepristone and letrozole is as effective in treating ectopic pregnancies.

Ectopic pregnancy – Ectopic pregnancy occurs when a fertilized egg implants and grows outside the main cavity of the uterus, most commonly in a fallopian tube. This condition can cause the tube to rupture if not addressed, leading to internal bleeding. Initially, symptoms may be similar to a normal pregnancy, such as missed periods and breast tenderness. As it progresses, symptoms can include abdominal pain, vaginal bleeding, and dizziness. The condition can lead to significant complications if the growing tissue causes damage to nearby organs. It requires careful monitoring to prevent further health issues.

Trial ID:

2023-503935-16-00

Protocol code:

WML23

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Mifepristone and Letrozole for Treating Ectopic Pregnancy in Comparison to Methotrexate

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?