Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

ConditionEctopic Pregnancy

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age20-35

SponsorKafrelsheikh University

About this trial

The aim of work is to study the effectiveness of letrozole in treatment of early undisturbed ectopic pregnancy in comparison with Methotrexate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed ectopic pregnancy on trans vaginal ultrasound

Age between 20 and 35 years

A β-hCG levels < 3000 Iu/ L

The average diameter of the adnexal mass ≤3.5 cm

Disqualifiers

Presence of fetal heart pulsation

Heterotopic pregnancy

Presence of significant abdominal pain

history of allergic reactions to MTX or letrozole

Trial design

Design model

Parallel

Treatments tested in this trial

Methotrexate (drug)
Drug
Methotrexate is a folic acid antagonist that inhibits the enzyme dihydrofolate reductase, which converts folic acid to tetrahydrofolate, a cofactor needed in DNA and RNA synthesis
Letrozole 2.5Mg Tab
Drug
Aromatase inhibitors has been shown toSuccessfully block estrogen production In the absence of estrogen priming, progesterone may not exert its physiological functions due to a negative effect on progesterone receptors. It was hypothesized that by inhibiting the estrogen synthetase (the aromatase enzyme), the progesterone would not exert its physiological function in maintaining pregnancy, including ectopic pregnancy

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: MethotrexateActive comparator 1 intervention

Group B: LetrozoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

Resolution of complain

follow up by β-hCG on day 4 and day 7 of first dose

Time frame

β-hCG will be repeated weekly till negative or until the maximum dose of medication is reached (four doses of Methotrexate , whichever comes first).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: