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New treatment option for Ectopic Pregnancy
Official title Use of Letrozole for Ectopic Pregnancy
ClinicalTrials.gov ID: NCT06354439
What this study is testing
What is Letrozole tablets?
Letrozole tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ectopic pregnancy.
Also referred to as letrozole 2,5mg - 4 tables.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 18 years or older
- Diagnosis of ectopic pregnancy
- Desire for reproduction
- Ease of return
- Undetermined pregnancy location with abnormal hCG growth
You likely can't join if
- Presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician)
- Allergy to methotrexate or letrozole
- A reduction in β-hCG ≥ 50% in 2 measurements with 48 hours between them or ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization
- Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal)
- Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min)
- Hemoglobin \<10 g/dl
See the full eligibility criteria
- 18 years or older
- Diagnosis of ectopic pregnancy
- Desire for reproduction
- Ease of return
- Undetermined pregnancy location with abnormal hCG growth
- Presence of a heterogeneous adnexal mass on pelvic ultrasound suggestive of a tubal ectopic pregnancy with an hCG level ≤ 3000 mIU/ml
- Absence of fetal cardiac activity
- Average diameter of the adnexal mass ≤ 3.5 cm
- Hemodynamically stable
- No significant abdominal pain (i.e, \< 6 on a visual analog scale)
- Presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician)
- Allergy to methotrexate or letrozole
- A reduction in β-hCG ≥ 50% in 2 measurements with 48 hours between them or ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization
- Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal)
- Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min)
- Hemoglobin \<10 g/dl
- Platelets \<120.000/ml
- Presence of heterotopic pregnancy
- Do not wish to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.