Ectopic PregnancyPhase 4letrezoleNCT05198141
Evaluation of Different Doses of Letrozole in Ectopic Pregnancy
A Phase 4 study testing Letrozole tablets and laparoscopic salpingectomy in people with Ectopic Pregnancy, run by Zagazig University at 1 site in Egypt.
Trial summary
The utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Letrozole tablets and laparoscopic salpingectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2020to 1 Jan 2022
- Phase
- Phase 4
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed ectopic pregnancy was by
- Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
- β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).
Who cannot join
- Patients had contraindications for letrozole
- Patients with any systemic disease ( diabetes, hypertension, ....)
- Patients with b-hCG levels >3,000 mIU/mL
- Patients with hemoglobin level <10 g/dL,
- Patients with platelets count <150,000/mL,
- Patients with elevated liver enzymes,
- Patients with elevated blood urea, or serum creatinine
- The presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy
The utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole.
Read the detailed description
Letrozole, an aromatase inhibitor, has recently been introduced as favorable medical treatment for ectopic pregnancy. We aimed at evaluating the effects of different doses of letrozole for induction of abortion Sixty patients with undisturbed ectopic pregnancy were classified into three equal groups. Group I: The control group that contained women who were undergoing laparoscopic salpingectomy, Group II: Patients who received letrozole (5 mg d-1) for 10 d, and Group III: Patients who received letrozole (10 mg d-1) for 10 d. After that, the human chorionic gonadotropin (β-hCG) levels were determined for the first day and after 11 d of treating. letrozole (10 mg d-1) markedly reduced the receptors of estrogen and progesterone, and subsequent vascular endothelial growth factor signals, resulting in marked apoptosis in the placenta tissue. The utilization of letrozole at a dose of 10 mg d-1 for inducement of abortion typically results in a substantial high-successful rate without any severe side effects.
- Conditions
- Ectopic Pregnancy
- Being tested
- Letrozole tablets, laparoscopic salpingectomy
- Keywords
- LETREZOLE, Ectopic pregnancy, Induced abortion
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole tabletsDrug
Also called Femara
GI: Patients who were undergoing laparoscopic salpingectomy GII: patients who medically treated with 5 mg d-1 of letrozole using two tablets (2.5 mg of Femara) every day for 10 d GIII patients who medically treated with 10 mg d-1 of letrozole using four tablets (2.5 mg of Femara) every day for 10 d (group III)
laparoscopic salpingectomyProcedure or surgery
laparoscopic salpingectomy
| Study group | Role | What they receive |
|---|---|---|
| Control group I (GI) | Active comparator | Patients who were undergoing surgical treatment Receives: Procedure: laparoscopic salpingectomy |
| low dose letrozole group II (GII) | Experimental | patients who were medically treated with 5 mg of letrozole Receives: Drug: Letrozole tablets |
| High dose letrozole group (GIII) | Experimental | patients who were medically treated with 10 mg of letrozole using Receives: Drug: Letrozole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
β-hCG level
A quantitative human chorionic gonadotropin
Measured: The β-hCG levels were assessed on the 1st of treatment
β-hCG level
A quantitative human chorionic gonadotropin
Measured: The β-hCG levels were assessed on the 11th day of treatment
Secondary outcomes (10)
Complete blood count (CBC)
Complete blood count
Measured: Assessed on the 1st day of treatment
Alanine Amino Transferase (ALT)
Liver enzyme
Measured: Assessed on the 1st and 11th day of treatment
Aspartate aminotransferase (AST)
Liver enzyme
Measured: Assessed on the 1st and 11th day of treatment
Serum creatinine
Renal function test
Measured: Assessed on the 1st and 11th day of treatment
Blood urea
Renal function test
Measured: Assessed on the 1st and 11th day of treatment
Complete blood count (CBC)
Complete blood count
Measured: Assessed on the 11th day of treatment
Alanine Amino Transferase (ALT)
Liver enzyme
Measured: Assessed on the 11th day of treatment
Aspartate aminotransferase (AST)
Liver enzyme
Measured: Assessed on the 11th day of treatment
Serum creatinine
Renal function test
Measured: Assessed on the 11th day of treatment
Blood urea
Renal function test
Measured: Assessed on the 11th day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start15 Dec 2020
- Primary completion20 Nov 2021
- Study completion1 Jan 2022
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 Zagazig 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Ali Alabiad, MD, Zagazig University
- Investigators
- Ahmed I Heraiz, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198141
- Sponsor's protocol ID
- LETROZOLE ON ECTOPIC PREGNANCY
- Acronym
- letrezole
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Table Statistical analysis Master sheet raw data (excel sheet)
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Doses of Aromatase Inhibitor Letrozole for the Treatment of Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT05198141
- Acronym / sponsor ID
- letrezole / LETROZOLE ON ECTOPIC PREGNANCY
- Conditions
- Ectopic Pregnancy
- Keywords
- LETREZOLE, Ectopic pregnancy, Induced abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 20 Jan 2022 (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 utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole.
Detailed description
Letrozole, an aromatase inhibitor, has recently been introduced as favorable medical treatment for ectopic pregnancy. We aimed at evaluating the effects of different doses of letrozole for induction of abortion Sixty patients with undisturbed ectopic pregnancy were classified into three equal groups. Group I: The control group that contained women who were undergoing laparoscopic salpingectomy, Group II: Patients who received letrozole (5 mg d-1) for 10 d, and Group III: Patients who received letrozole (10 mg d-1) for 10 d. After that, the human chorionic gonadotropin (β-hCG) levels were determined for the first day and after 11 d of treating. letrozole (10 mg d-1) markedly reduced the receptors of estrogen and progesterone, and subsequent vascular endothelial growth factor signals, resulting in marked apoptosis in the placenta tissue. The utilization of letrozole at a dose of 10 mg d-1 for inducement of abortion typically results in a substantial high-successful rate without any severe side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group I (GI) | Active comparator | Procedure: laparoscopic salpingectomyPatients who were undergoing surgical treatment |
| low dose letrozole group II (GII) | Experimental | Drug: Letrozole tabletspatients who were medically treated with 5 mg of letrozole |
| High dose letrozole group (GIII) | Experimental | Drug: Letrozole tabletspatients who were medically treated with 10 mg of letrozole using |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed ectopic pregnancy was by
- Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
- β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).
Key exclusion criteria (8 listed)
- Patients had contraindications for letrozole
- Patients with any systemic disease ( diabetes, hypertension, ....)
- Patients with b-hCG levels >3,000 mIU/mL
- Patients with hemoglobin level <10 g/dL,
- Patients with platelets count <150,000/mL,
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 tabletsAlso: FemaraGI: Patients who were undergoing laparoscopic salpingectomy GII: patients who medically treated with 5 mg d-1 of letrozole using two tablets (2.5 mg of Femara) every day for 10 d GIII patients who medically treated with 10 mg d-1 of letrozole using four tablets (2.5 mg of Femara) every day for 10 d (group III) | Drug | High dose letrozole group (GIII), low dose letrozole group II (GII) |
| laparoscopic salpingectomylaparoscopic salpingectomy | Procedure or surgery | Control group I (GI) |
Primary outcome
β-hCG level
Time frame: The β-hCG levels were assessed on the 1st of treatment
A quantitative human chorionic gonadotropin
β-hCG level
Time frame: The β-hCG levels were assessed on the 11th day of treatment
A quantitative human chorionic gonadotropin
10 secondary outcomes
Complete blood count (CBC)
Time frame: Assessed on the 1st day of treatment
Alanine Amino Transferase (ALT)
Time frame: Assessed on the 1st and 11th day of treatment
Aspartate aminotransferase (AST)
Time frame: Assessed on the 1st and 11th day of treatment
Serum creatinine
Time frame: Assessed on the 1st and 11th day of treatment
Blood urea
Time frame: Assessed on the 1st and 11th day of treatment
Complete blood count (CBC)
Time frame: Assessed on the 11th day of treatment
Alanine Amino Transferase (ALT)
Time frame: Assessed on the 11th day of treatment
Aspartate aminotransferase (AST)
Time frame: Assessed on the 11th day of treatment
Serum creatinine
Time frame: Assessed on the 11th day of treatment
Blood urea
Time frame: Assessed on the 11th day of treatment
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 20 Jan 2022.
- Individual participant dataSharing planned: Yes. Table Statistical analysis Master sheet raw data (excel sheet)
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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.
Ahmed I Heraiz, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole tablets and laparoscopic salpingectomy in people with Ectopic Pregnancy, run by Zagazig 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 3 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: finished, as of the sponsor's last update on 20 Jan 2022. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
β-hCG level (time frame: The β-hCG levels were assessed on the 1st of treatment). The study lists 2 primary outcomes in all. 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 20 Jan 2022.