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New treatment option for Early Pregnancy Loss
Official title Letrozole and Misoprostol for Early Pregnancy Loss Management
ClinicalTrials.gov ID: NCT06452719
What this study is testing
What is Letrozole?
Letrozole is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for early pregnancy loss.
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 pilot cohort study to preliminarily investigate the efficacy of pretreatment with letrozole 10 mg daily for three consecutive days followed by treatment with misoprostol 800 mcg vaginally for medical management of early pregnancy loss in a US population. Patients will be followed to assess efficacy of this treatment regimen, as well as additional interventions needed, side effects, adverse events, and patient acceptability.
- Phase 2: a mid-size study of how well it works
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
- Able to participate in the informed consent process and provide a signed and dated consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Access to working mobile phone
- English-speaking
- Age 18 years or older
You likely can't join if
- Incomplete or inevitable abortion
- Contraindication of allergy to letrozole or misoprostol
- Unable to return for clinic-based follow-up
- Twin or multiple pregnancy
See the full eligibility criteria
- Able to participate in the informed consent process and provide a signed and dated consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Access to working mobile phone
- English-speaking
- Age 18 years or older
- Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth...
- Incomplete or inevitable abortion
- Contraindication of allergy to letrozole or misoprostol
- Unable to return for clinic-based follow-up
- Twin or multiple pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
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 Philadelphia, Pennsylvania, United States. 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.