Letrozole and Misoprostol for Early Pregnancy Loss Management
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Incomplete or inevitable abortion
Contraindication of allergy to letrozole or misoprostol
Unable to return for clinic-based follow-up
Twin or multiple pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Letrozole
DrugLetrozole 10 mg orally daily for three consecutive days
Misoprostol
DrugMisoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Letrozole & MisprostolExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Treatment Efficacy
Absence of gestational sac on transvaginal ultraound
Time frame
Visit 2 (Days 10-11)Secondary outcomes
1
Acceptability
Participant assessment of treatment (Positive / Neutral / Negative), Likelihood to recommend this method of treatment to a friend (Yes / No)
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov