Abortion Induced ComplicatedPhase 1/2NCT07767435
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
A Phase 1/2 study testing · Misoprostol + letrozole and misoprostol alone in people with Abortion Induced Complicated and Abortion, run by Sohag University.
Trial summary
Termination of Second trimester Abortion with Letrozole and Misoprostol Compared to Misoprostol Alone Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abortion Induced Complicated, Abortion
- What is being tested?
- · Misoprostol + letrozole and misoprostol alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Jun 2027
- Phase
- Phase 1/2
- 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
- Pregnant women aged 18-45 years.
- Failed pregnancy.
- Gestational age between 14 and 20weeks, confirmed by ultrasonography on the day of admission.
- Hemoglobin concentration >9 g/dL.
- Closed cervix.
- Absence of products of conception in the cervical canal.
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- Exclusion Criteria:
- Previous attempt to terminate the current pregnancy.
- Molar pregnancy (hydatidiform mole).
- Pathological uterine lesions including uterine fibroids and congenital uterine malformations.
- Cardiac disease.
- Renal disease.
- Hemorrhagic disorders.
- Body mass index (BMI) >35 kg/m².
- Documented hypersensitivity or allergy to letrozole, misoprostol, or any of the study medications.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Termination of Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Termination of Second trimester Abortion with Letrozole and Misoprostol Compared to Misoprostol Alone
Read the detailed description
An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:
- Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol.
- Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment.
This study will be open-label due to different drugs and route of administrations used.
- Conditions
- Abortion Induced Complicated, Abortion
- Being tested
- · Misoprostol + letrozole, misoprostol alone
- Keywords
- medical abortion, induced abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
· Misoprostol + letrozoleDrug
- to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy.
- to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion.
misoprostol aloneDrug
- to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy.
- to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion
| Study group | Role | What they receive |
|---|---|---|
| Group I (Letrozole + Misoprostol) | Active comparator | Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol Receives: Drug: · Misoprostol + letrozole |
| Group II (Misoprostol alone | Active comparator | · Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment. Receives: Drug: misoprostol alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
· Complete abortion rate.
Measured: 1 weak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion Induced ComplicatedStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: * Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol. * Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment. This study will be open-label due to different drugs and route of administrations used.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khalifa Ahmed Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767435
- Sponsor's protocol ID
- Soh-Med-26-7-23MS
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Termination of Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
- ClinicalTrials.gov ID
- NCT07767435
- Acronym / sponsor ID
- Soh-Med-26-7-23MS
- Conditions
- Abortion Induced Complicated, Abortion
- Keywords
- medical abortion, induced abortion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 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.
Termination of Second trimester Abortion with Letrozole and Misoprostol Compared to Misoprostol Alone
Detailed description
An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:
- Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol.
- Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment.
This study will be open-label due to different drugs and route of administrations used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: * Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol. * Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment. This study will be open-label due to different drugs and route of administrations used.
| Arm | Type | Receives |
|---|---|---|
| Group I (Letrozole + Misoprostol) | Active comparator | Drug: · Misoprostol + letrozoleGroup I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol |
| Group II (Misoprostol alone | Active comparator | Drug: misoprostol alone· Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Pregnant women aged 18-45 years.
- Failed pregnancy.
- Gestational age between 14 and 20weeks, confirmed by ultrasonography on the day of admission.
- Hemoglobin concentration >9 g/dL.
- Closed cervix.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| · Misoprostol + letrozole1. to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy. 2. to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion. | Drug | Group I (Letrozole + Misoprostol) |
| misoprostol alone1. to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy. 2. to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion | Drug | Group II (Misoprostol alone |
Primary outcome
· Complete abortion rate.
Time frame: 1 weak
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 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing · Misoprostol + letrozole and misoprostol alone in people with Abortion Induced Complicated and Abortion, run by Sohag 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 15 inclusion and 0 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 17 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Contact ahmed khalifa elsayed, resident (01142626766, AhmedKhalifa.ahmedelsayed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
· Complete abortion rate. (time frame: 1 weak). 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 17 Aug 2026.