Ectopic PregnancyNCT04308343
The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
A study testing Methotrexate, Letrozole and cetrotide in people with Ectopic Pregnancy, run by Assiut University.
Trial summary
The aim of this study is to : 1. Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate. 2. Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Methotrexate, Letrozole and cetrotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2020to 1 Sep 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have undisturbed ectopic pregnancy .Who are:
- have no significant pain
- have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm with no visible heartbeat
- have a serum human chorionic gonadotropins level less than 1,500 IU/litre
- do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) .
Who cannot join
- An undisturbed ectopic pregnancy and significant pain
- An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger
- An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan
- An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 IU/litre or more
- intrauterine pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to :
- Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate.
- Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.
- Conditions
- Ectopic Pregnancy
- Being tested
- Methotrexate, Letrozole, cetrotide
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Drugs to treat undisturbed ectopic pregnancies
LetrozoleDrug
Drugs to treat undisturbed ectopic pregnancies
cetrotideDrug
Drugs to treat undisturbed ectopic pregnancies
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate group | Active comparator | Not described Receives: Drug: Methotrexate |
| Letrozole group | Active comparator | Not described Receives: Drug: Letrozole |
| Gonadotropins releasing hormone antagonist group | Active comparator | Not described Receives: Drug: cetrotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated .
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start30 Mar 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (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 Assiut 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali saber ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308343
- Sponsor's protocol ID
- Aromatase inhibitor in ectopic
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT04308343
- Acronym / sponsor ID
- Aromatase inhibitor in ectopic
- Conditions
- Ectopic Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 16 Mar 2020 (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 of this study is to :
- Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate.
- Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methotrexate group | Active comparator | Drug: Methotrexate |
| Letrozole group | Active comparator | Drug: Letrozole |
| Gonadotropins releasing hormone antagonist group | Active comparator | Drug: cetrotide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who have undisturbed ectopic pregnancy .Who are:
Key exclusion criteria (5 listed)
- An undisturbed ectopic pregnancy and significant pain
- An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger
- An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan
- An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 IU/litre or more
- intrauterine pregnancy
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 |
|---|---|---|
| MethotrexateDrugs to treat undisturbed ectopic pregnancies | Drug | Methotrexate group |
| LetrozoleDrugs to treat undisturbed ectopic pregnancies | Drug | Letrozole group |
| cetrotideDrugs to treat undisturbed ectopic pregnancies | Drug | Gonadotropins releasing hormone antagonist group |
Primary outcome
determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated .
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate, Letrozole and cetrotide in people with Ectopic Pregnancy, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 16 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Saber Ali, M.Sc (01095567589, kenous87@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated . (time frame: 3 months). 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 16 Mar 2020.