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CompletedNCT06426979Updated May 28, 2024

Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy

An interventional study of Methotrexate and Letrozole in Pregnancy Tubal, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to female participants aged 22 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
22 Years to 60 Years
Sex
Female
01

Study summary

Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP.

02

Conditions studied

  • Pregnancy Tubal
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Zagazig University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Presence of gestational masses of \<3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity;
  • Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of \<3500 IU/L.

Exclusion criteria

Exclusion Criteria:

  • Free of Inclusion Criteria
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    Group LTZ-MTX

    Letrozole and Methotrexate Therapy's Group

    Drug: Methotrexate · Drug: Letrozole

  • Active comparator
    Group MTX

    Methotrexate Therapy's Group

    Drug: Methotrexate

Interventions

  • DrugMethotrexate

    Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2.

  • DrugLetrozole

    FEMARA 2.5 mg tablets two tablets daily

06

What researchers measure

Primary outcomes

  1. The Rate of resolution of Tubal Ectopic Pregnancy (TEP)

    Role of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery.

    Time frame: 9 months

07

Study locations

1 site
  • Zagazig university
    Zagazig, Ash Sharqia Governorate 44519, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Jun 2023, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2024
First posted
May 23, 2024
StartActual
Jan 1, 2023
Primary completionActual
Jun 1, 2023
CompletionActual
Jan 1, 2024
Last update
May 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06426979
Lead sponsor
Zagazig University
Responsible party
Walid Mohamed Elnagar (Assistant professor of Gynecology, Zagazig University) — Principal investigator
First posted
May 23, 2024
Start date
Jan 1, 2023
Primary completion
Jun 1, 2023
Completion
Jan 1, 2024
Last update
May 28, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Letrozole

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