LetrozoleNCT07636317
Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion
A study testing Letrozole + Misoprostol and Misoprostol in people with Letrozole and Misoprostol, run by Sohag University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Letrozole, Misoprostol, Induction
- What is being tested?
- Letrozole + Misoprostol and Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2025to 1 Mar 2026
- Phase
- Interventional
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 45 years.
- Women with nonviable pregnancies undergoing 1st-trimester abortion.
Who cannot join
- Medical diseases like renal or liver disease.
- Severe bleeding and shocked patients.
- Inevitable abortion.
- Hypersensitivity to any of the drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion: A Randomized Controlled Trial
This study aimed to evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone.
Read the detailed description
Inducing abortion by drugs is an alternative for surgery intervention, which has economic benefits with lower side effects and its rate of success is 60 to 95%.
Letrozole is also one of aromatase inhibitors, which is used to stimulate ovulation in infertile women suffering ovulatory dysfunction. This drug is one of the main drugs for inhibiting aromatase, with a relatively short 45-hour half life, which is active orally and inhibits aromatase enzyme reversibly.
Misoprostol is a relatively safe drug and of its side effects it is possible to mention to gestational effects, feeling of warmth, and shivering. Severe side effects of misoprostol consumption are severe bleeding and endometritis, with less than 1% prevalence based on studies.
- Conditions
- Letrozole, Misoprostol, Induction, Missed Abortion
- Being tested
- Letrozole + Misoprostol, Misoprostol
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole + MisoprostolDrug
Patients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes.
MisoprostolDrug
Patients received only 800 µg of Misoprostol.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes. Receives: Drug: Letrozole + Misoprostol |
| Group 2 | Active comparator | Patients received only 800 µg of Misoprostol. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding
Incidence of bleeding was recorded.
Measured: 7 days following the Misoprostol dose
Secondary outcomes (3)
Number of dosages of prostaglandins
Number of dosages of prostaglandins was recorded.
Measured: 7 days following the Misoprostol dose
Duration required for abortion
Duration required for abortion was recorded.
Measured: 7 days following the Misoprostol dose
Incidence of adverse effects
Incidence of adverse effects such as nausea, vomiting, gastric distress, headache, fever, and shivers were recorded.
Measured: 7 days following the Misoprostol dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start14 Jun 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
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 Sohag 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
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mahmoud Ahmed Elkhalily, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636317
- Sponsor's protocol ID
- Soh-Med-24-6-8PD.
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07636317
- Acronym / sponsor ID
- Soh-Med-24-6-8PD.
- Conditions
- Letrozole, Misoprostol, Induction, Missed Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 9 Jun 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.
This study aimed to evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone.
Detailed description
Inducing abortion by drugs is an alternative for surgery intervention, which has economic benefits with lower side effects and its rate of success is 60 to 95%.
Letrozole is also one of aromatase inhibitors, which is used to stimulate ovulation in infertile women suffering ovulatory dysfunction. This drug is one of the main drugs for inhibiting aromatase, with a relatively short 45-hour half life, which is active orally and inhibits aromatase enzyme reversibly.
Misoprostol is a relatively safe drug and of its side effects it is possible to mention to gestational effects, feeling of warmth, and shivering. Severe side effects of misoprostol consumption are severe bleeding and endometritis, with less than 1% prevalence based on studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Letrozole + MisoprostolPatients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes. |
| Group 2 | Active comparator | Drug: MisoprostolPatients received only 800 µg of Misoprostol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age from 18 to 45 years.
- Women with nonviable pregnancies undergoing 1st-trimester abortion.
Key exclusion criteria (4 listed)
- Medical diseases like renal or liver disease.
- Severe bleeding and shocked patients.
- Inevitable abortion.
- Hypersensitivity to any of the drugs.
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 |
|---|---|---|
| Letrozole + MisoprostolPatients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes. | Drug | Group 1 |
| MisoprostolPatients received only 800 µg of Misoprostol. | Drug | Group 2 |
Primary outcome
Incidence of bleeding
Time frame: 7 days following the Misoprostol dose
Incidence of bleeding was recorded.
3 secondary outcomes
Number of dosages of prostaglandins
Time frame: 7 days following the Misoprostol dose
Duration required for abortion
Time frame: 7 days following the Misoprostol dose
Incidence of adverse effects
Time frame: 7 days following the Misoprostol dose
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 study testing Letrozole + Misoprostol and Misoprostol in people with Letrozole and Misoprostol, run by Sohag University at 1 site in Egypt.
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 2 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 9 Jun 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 Egypt. 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.
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?
Incidence of bleeding (time frame: 7 days following the Misoprostol dose). 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 9 Jun 2026.