Early Pregnancy LossPhase 2LeMiNCT06452719
Letrozole and Misoprostol for Early Pregnancy Loss Management
A Phase 2 study testing Letrozole and Misoprostol in people with Early Pregnancy Loss and Miscarriage in First Trimester, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Pregnancy Loss, Miscarriage in First Trimester, Miscarriage
- What is being tested?
- Letrozole and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2024to 14 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 pattern diagnostic of early pregnancy failure)
Who cannot join
- Incomplete or inevitable abortion
- Contraindication of allergy to letrozole or misoprostol
- Unable to return for clinic-based follow-up
- Twin or multiple pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
PEACE / Penn Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
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.
- Being tested
- Letrozole, Misoprostol
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Letrozole 10 mg orally daily for three consecutive days
MisoprostolDrug
Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
| Study group | Role | What they receive |
|---|---|---|
| Letrozole & Misprostol | Experimental | Letrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose Receives: Drug: Letrozole; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy
Absence of gestational sac on transvaginal ultraound
Measured: 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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start22 Aug 2024
- Primary completion16 Apr 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy LossStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452719
- Sponsor's protocol ID
- 855835
- Acronym
- LeMi
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT06452719
- Acronym / sponsor ID
- LeMi / 855835
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole & Misprostol | Experimental | Drug: Letrozole, Drug: MisoprostolLetrozole 10 mg orally daily for three consecutive days followed by misoprostol 800 mcg vaginally within 24 hours of final letrozole dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Incomplete or inevitable abortion
- Contraindication of allergy to letrozole or misoprostol
- Unable to return for clinic-based follow-up
- Twin or multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleLetrozole 10 mg orally daily for three consecutive days | Drug | Letrozole & Misprostol |
| MisoprostolMisoprostol 800 mcg vaginally within 24 hours of final letrozole dose | Drug | Letrozole & Misprostol |
Primary outcome
Treatment Efficacy
Time frame: Visit 2 (Days 10-11)
Absence of gestational sac on transvaginal ultraound
1 secondary outcome
Acceptability
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole and Misoprostol in people with Early Pregnancy Loss and Miscarriage in First Trimester, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy (time frame: Visit 2 (Days 10-11)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.