Letrozole + Misoprostol for Miscarriage
(LeMi Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for women experiencing early pregnancy loss, also known as miscarriage. The researchers aim to determine if taking letrozole, a medication typically used for certain types of breast cancer, for three days followed by misoprostol, a common medication for managing miscarriages, can effectively aid the body in managing the miscarriage process. The trial is open to English-speaking women diagnosed with early pregnancy loss, confirmed by an ultrasound showing no fetal heartbeat. Participants must be willing to follow study procedures and attend follow-up visits. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using letrozole with misoprostol is generally safe for treating early pregnancy loss. Studies have found that this combination can increase the chances of a complete abortion without adding extra side effects. One study found that using letrozole first, followed by misoprostol, was moderately successful and did not cause any unexpected side effects. This indicates that the treatment is usually well-tolerated. While some side effects might still occur, they are not unusual or severe based on current evidence.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for miscarriage, which typically involves misoprostol alone or surgical procedures, this new treatment approach combines letrozole and misoprostol. Letrozole is a medication that helps prepare the uterus by reducing estrogen levels, potentially enhancing the effectiveness of misoprostol, which is used to induce uterine contractions. Researchers are excited about this combination because it might improve treatment effectiveness and speed up recovery time compared to using misoprostol alone.
What evidence suggests that this treatment might be an effective treatment for miscarriage?
Research shows that using letrozole before misoprostol can improve the treatment of early pregnancy loss. In this trial, participants will take Letrozole 10 mg orally daily for three consecutive days, followed by misoprostol 800 mcg vaginally within 24 hours of the final letrozole dose. One study found that this combination resulted in a complete abortion rate of 76.7%. Another study discovered that taking letrozole for three days before using misoprostol was more effective than using misoprostol alone. Additionally, a different trial reported a complete abortion rate of 85% when both letrozole and misoprostol were used. These findings suggest that letrozole may enhance the effectiveness of misoprostol in managing early pregnancy loss.23678
Are You a Good Fit for This Trial?
This trial is for English-speaking adults over 18 who have had an early pregnancy loss, as confirmed by ultrasound. Participants must be willing to follow the study's procedures, have a working mobile phone, and can sign a consent form. It's not for those with incomplete abortion, allergies to the drugs being tested, unable to return for follow-up, or having multiple pregnancies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pretreatment
Participants receive letrozole 10 mg orally daily for three consecutive days
Treatment
Participants receive misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Follow-up
Participants are monitored for efficacy, additional interventions, side effects, adverse events, and patient acceptability
What Are the Treatments Tested in This Trial?
Interventions
- Letrozole
- Misoprostol
Letrozole is already approved in United States, European Union, Canada for the following indications:
- Breast cancer in postmenopausal women
- Increasing the chance of ovulation in women with polycystic ovary syndrome
- Early breast cancer in postmenopausal women
- Advanced breast cancer in postmenopausal women
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor