Ectopic PregnancyPhase 2/3NCT07842796
Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.
A Phase 2/3 study testing Letrozole and Methotrexate in people with Ectopic Pregnancy, run by Benha University at 1 site in Egypt.
Trial summary
This study evaluates two medical strategies designed to minimize surgical intervention and reduce methotrexate (MTX) exposure in women with undisturbed tubal ectopic pregnancy (TEP). Read more about this study
- Who is it for?
- Ages 24 to 45 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Letrozole and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 12 Dec 2026
- Phase
- Phase 2/3
- 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 24 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis: Confirmed undisturbed/intact unilateral tubal ectopic pregnancy (TEP) presenting with lower abdominal pain and absence of vaginal bleeding.
- Pre-treatment beta-hCG Level: Baseline serum beta-human chorionic gonadotropin (beta-hCG) level of less than 3,500 IU/L.
- Ectopic Mass Dimensions: Gestational mass with a maximum diameter of less than 3.5 cm measured on transvaginal ultrasonography (TVU).
- Ultrasound Integrity: Absence of transvaginal ultrasound features indicating hemoperitoneum or active intraperitoneal bleeding.
- Informed Consent: Willingness to comply with follow-up schedules and provision of written informed consent.
Who cannot join
- Disturbed Ectopic Pregnancy: Clinical, laboratory, or ultrasound evidence of tubal rupture, hemoperitoneum, or active intra-abdominal hemorrhage.
- Elevated beta-hCG: Serum beta-hCG levels equal to or exceeding 3,500 IU/L at baseline.
- Mass Size: Gestational mass diameter > 3.5 cm.
- Contraindications to Methotrexate or Letrozole: Known hypersensitivity or contraindications to therapy (e.g., active hepatic, renal, or hematological dysfunctions).
- Non-compliance: Inability or unwillingness to comply with the serial post-treatment beta-hCG monitoring and follow-up protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimizing Surgical Intervention in Tubal Ectopic Pregnancy: A Randomized Comparison Between Sequential and Combined Letrozole and Single-Dose Methotrexate Regimens.
This study evaluates two medical strategies designed to minimize surgical intervention and reduce methotrexate (MTX) exposure in women with undisturbed tubal ectopic pregnancy (TEP). Participants with undisturbed TEP and pre-treatment serum $\beta$-hCG levels $<3500\text{ IU/L}$ are randomized to receive either a sequential regimen (initial letrozole monotherapy, reserving MTX only for treatment non-responders) or a combined regimen (simultaneous letrozole and single-dose MTX from day one). The study aims to compare the overall success rate of resolving TEP without emergency surgery, as well as the ability of the sequential approach to avoid MTX administration altogether.
- Conditions
- Ectopic Pregnancy
- Being tested
- Letrozole, Methotrexate
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Oral Letrozole 5 mg/day (2 times 2.5{ mg} tablets daily) for 4 days. If serum beta-hCG drops by >10% on Day 4, Letrozole is continued.
MethotrexateDrug
A single intramuscular injection of Methotrexate (50mg/m) is administered as rescue therapy, If beta-hCG drop is <10 on Day 4,
| Study group | Role | What they receive |
|---|---|---|
| Sequential Protocol | Active comparator | Participants in this arm initially receive oral Letrozole at a dose of 5 mg daily (administered as two 2.5 mg film-coated tablets once daily) for 4 consecutive days. On Day 4, serum beta-hCG levels are evaluated to specify if rescue needed we will give a single intramuscular rescue injection of Methotrexate (50mg/m) while continuing Letrozole for an additional 7 days. Receives: Drug: Letrozole; Drug: Methotrexate |
| Combined Protocol | Active comparator | Participants in this arm receive simultaneous dual drug therapy starting on Day 1 Receives: Drug: Letrozole; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Letrozole Standalone Success Rate
Resolution of tubal ectopic pregnancy (confirmed by TVU and beta-hCG < 15 IU/L) achieved via Letrozole monotherapy without requiring Methotrexate or surgical intervention
Measured: 19 days post-initiation oftreatment treatment.
Secondary outcomes (1)
Avoidance of Surgery
: Resolution of ectopic pregnancy (beta-hCG < 15 IU/L) using medical management alone, avoiding conversion to emergency surgery (salpingectomy/salpingotomy).
Measured: 19 days post-initiation oftreatment treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Dec 2024
- Primary completion10 Jul 2026
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by Benha 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842796
- Sponsor's protocol ID
- RC: 1/12/2024
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Surgical Intervention in Tubal Ectopic Pregnancy: A Randomized Comparison Between Sequential and Combined Letrozole and Single-Dose Methotrexate Regimens.
- ClinicalTrials.gov ID
- NCT07842796
- Acronym / sponsor ID
- RC: 1/12/2024
- Conditions
- Ectopic Pregnancy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 25 Sep 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 evaluates two medical strategies designed to minimize surgical intervention and reduce methotrexate (MTX) exposure in women with undisturbed tubal ectopic pregnancy (TEP). Participants with undisturbed TEP and pre-treatment serum $\beta$-hCG levels $<3500\text{ IU/L}$ are randomized to receive either a sequential regimen (initial letrozole monotherapy, reserving MTX only for treatment non-responders) or a combined regimen (simultaneous letrozole and single-dose MTX from day one). The study aims to compare the overall success rate of resolving TEP without emergency surgery, as well as the ability of the sequential approach to avoid MTX administration altogether.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential Protocol | Active comparator | Drug: Letrozole, Drug: MethotrexateParticipants in this arm initially receive oral Letrozole at a dose of 5 mg daily (administered as two 2.5 mg film-coated tablets once daily) for 4 consecutive days. On Day 4, serum beta-hCG levels are evaluated to specify if rescue needed we will give a single intramuscular rescue injection of Methotrexate (50mg/m) while continuing Letrozole for an additional 7 days. |
| Combined Protocol | Active comparator | Drug: Letrozole, Drug: MethotrexateParticipants in this arm receive simultaneous dual drug therapy starting on Day 1 |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis: Confirmed undisturbed/intact unilateral tubal ectopic pregnancy (TEP) presenting with lower abdominal pain and absence of vaginal bleeding.
- Pre-treatment beta-hCG Level: Baseline serum beta-human chorionic gonadotropin (beta-hCG) level of less than 3,500 IU/L.
- Ectopic Mass Dimensions: Gestational mass with a maximum diameter of less than 3.5 cm measured on transvaginal ultrasonography (TVU).
- Ultrasound Integrity: Absence of transvaginal ultrasound features indicating hemoperitoneum or active intraperitoneal bleeding.
- Informed Consent: Willingness to comply with follow-up schedules and provision of written informed consent.
Key exclusion criteria (5 listed)
- Disturbed Ectopic Pregnancy: Clinical, laboratory, or ultrasound evidence of tubal rupture, hemoperitoneum, or active intra-abdominal hemorrhage.
- Elevated beta-hCG: Serum beta-hCG levels equal to or exceeding 3,500 IU/L at baseline.
- Mass Size: Gestational mass diameter > 3.5 cm.
- Contraindications to Methotrexate or Letrozole: Known hypersensitivity or contraindications to therapy (e.g., active hepatic, renal, or hematological dysfunctions).
- Non-compliance: Inability or unwillingness to comply with the serial post-treatment beta-hCG monitoring and follow-up protocol.
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 |
|---|---|---|
| LetrozoleOral Letrozole 5 mg/day (2 times 2.5{ mg} tablets daily) for 4 days. If serum beta-hCG drops by >10% on Day 4, Letrozole is continued. | Drug | Combined Protocol, Sequential Protocol |
| MethotrexateA single intramuscular injection of Methotrexate (50mg/m) is administered as rescue therapy, If beta-hCG drop is <10 on Day 4, | Drug | Combined Protocol, Sequential Protocol |
Primary outcome
Letrozole Standalone Success Rate
Time frame: 19 days post-initiation oftreatment treatment.
Resolution of tubal ectopic pregnancy (confirmed by TVU and beta-hCG < 15 IU/L) achieved via Letrozole monotherapy without requiring Methotrexate or surgical intervention
1 secondary outcome
Avoidance of Surgery
Time frame: 19 days post-initiation oftreatment treatment.
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 25 Sep 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. 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 2/3 study testing Letrozole and Methotrexate in people with Ectopic Pregnancy, run by Benha 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Letrozole Standalone Success Rate (time frame: 19 days post-initiation oftreatment treatment.). 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 25 Sep 2026.