LetrozoleNCT07753655
The Value of Pretreatment With Letrozole on Induction Time of Medical Evacuation With Misoprostol in Cases of Missed Abortion
A study testing Intervention Group: letrozole followed by misoprostol in people with Letrozole, run by Cairo University.
Trial summary
The aim is to evaluate the effect of letrozole pretreatment on the induction time during medical evacuation using misoprostol in women diagnosed with missed abortion, and to compare its efficacy and safety to misoprostol alone. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Letrozole
- What is being tested?
- Intervention Group: letrozole followed by misoprostol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 - 45 years.
- Diagnosed with missed abortion confirmed by ultrasound (absent fetal heartbeat and/or no embryonic development).
- Gestational age ≤ 12 weeks based on last menstrual period
- Hemoglobin levels >10 g/dL.
- BMI ranging from 25 to 35 kg/m2.
- Hemodynamically stable and no signs of infection.
Who cannot join
- Incomplete abortion, inevitable abortion, or threatened miscarriage.
- Suspected ectopic pregnancy and molar pregnancy.
- History of allergy or contraindication to misoprostol or letrozole.
- Coagulopathy or use of anticoagulant medications.
- Chronic medical diseases (e.g., uncontrolled diabetes, cardiovascular disease, liver or renal dysfunction).
- Prior uterine surgery that contraindicates medical abortion (e.g., classical cesarean section, myomectomy with uterine entry).
- Uterine anomalies.
- Women unsure of LMP
About this study
The aim is to evaluate the effect of letrozole pretreatment on the induction time during medical evacuation using misoprostol in women diagnosed with missed abortion, and to compare its efficacy and safety to misoprostol alone.
- Conditions
- Letrozole
- Being tested
- Intervention Group: letrozole followed by misoprostol, Control Group: misoprostol only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group: letrozole followed by misoprostolProcedure or surgery
Group A (Intervention Group) will receive letrozole followed by misoprostol.
Control Group: misoprostol onlyProcedure or surgery
Group B (Control Group) will receive misoprostol only, without prior letrozole pretreatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: letrozole followed by misoprostol | Experimental | Group A will receive letrozole followed by misoprostol. Receives: Procedure: Intervention Group: letrozole followed by misoprostol |
| Control Group: misoprostol only | Active comparator | Group B will receive misoprostol only, without prior letrozole pretreatment. Receives: Procedure: Control Group: misoprostol only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of complete uterine evacuation
Time from misoprostol administration to complete uterine evacuation
Measured: one week following Misoprostol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LetrozoleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ali Abdullah Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753655
- Sponsor's protocol ID
- MS-616-2025
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Pretreatment With Letrozole on Induction Time of Medical Evacuation With Misoprostol in Cases of Missed Abortion
- ClinicalTrials.gov ID
- NCT07753655
- Acronym / sponsor ID
- MS-616-2025
- Conditions
- Letrozole
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Aug 2026 (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.
The aim is to evaluate the effect of letrozole pretreatment on the induction time during medical evacuation using misoprostol in women diagnosed with missed abortion, and to compare its efficacy and safety to misoprostol alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: letrozole followed by misoprostol | Experimental | Procedure: Intervention Group: letrozole followed by misoprostolGroup A will receive letrozole followed by misoprostol. |
| Control Group: misoprostol only | Active comparator | Procedure: Control Group: misoprostol onlyGroup B will receive misoprostol only, without prior letrozole pretreatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 - 45 years.
- Diagnosed with missed abortion confirmed by ultrasound (absent fetal heartbeat and/or no embryonic development).
- Gestational age ≤ 12 weeks based on last menstrual period
- Hemoglobin levels >10 g/dL.
- BMI ranging from 25 to 35 kg/m2.
Key exclusion criteria (8 listed)
- Incomplete abortion, inevitable abortion, or threatened miscarriage.
- Suspected ectopic pregnancy and molar pregnancy.
- History of allergy or contraindication to misoprostol or letrozole.
- Coagulopathy or use of anticoagulant medications.
- Chronic medical diseases (e.g., uncontrolled diabetes, cardiovascular disease, liver or renal dysfunction).
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 |
|---|---|---|
| Intervention Group: letrozole followed by misoprostolGroup A (Intervention Group) will receive letrozole followed by misoprostol. | Procedure or surgery | Intervention Group: letrozole followed by misoprostol |
| Control Group: misoprostol onlyGroup B (Control Group) will receive misoprostol only, without prior letrozole pretreatment | Procedure or surgery | Control Group: misoprostol only |
Primary outcome
Time of complete uterine evacuation
Time frame: one week following Misoprostol administration
Time from misoprostol administration to complete uterine evacuation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group: letrozole followed by misoprostol in people with Letrozole, run by Cairo University.
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 8 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time of complete uterine evacuation (time frame: one week following Misoprostol administration). 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 7 Aug 2026.