Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

NCT05918718 | Unknown Phase 1 FDA Drug

• 1 other identifier: IR.TUMS.IKHC.REC.1401.093
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, about 150 women diagnosed with ectopic pregnancy who are referred to the Obstetrics and Gynecology Center of Valiasr Hospital are included in the study. Demographic information including both gynecological and obstetrical data is collected. Ectopic ectopic pregnancy is confirmed by transvaginal ultrasound. The patients are randomly allocated to three groups The first group will receive a single dose of methotrexate The second group will receive letrozole within a 10-day period, twice a day The third group will receive letrozole in a 5-day period three times a day In the first group, the first day of drug injection is counted, and the drug is measured at a dose of 50 mg/m2 and divided intramuscularly. The hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day. In the second group, letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured. In the third group, letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14. Also, the level of blood cells, liver enzymes, urea level and serum creatinine level are measured on the first day and the seventh day after the treatment. The level of antimullerin hormone is measured on the first day and 3 months after the treatment.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (2)

• βhCG

  on day 14

• Anti mulerian hormone

  3 months

Study Arms (3)

methotrexate

EXPERIMENTAL

The first group will receive a single dose (50 mg/m2) of methotrexate The beta-hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.

Drug: methotrexate

Letrozole BD

EXPERIMENTAL

The first group will receive letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.

Drug: Letrozole

Letroozole TDS

EXPERIMENTAL

letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.

Drug: Letrozole

Interventions

Letrozole DRUG

assessment of the efficacy of Letrozole in treatment of ectopic pregnancy

Letroozole TDS; Letrozole BD

methotrexate DRUG

methotrexate

methotrexate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between 18-40 years of age who have spontaneously conceived and ectopic pregnancy has been definitively diagnosed.

You may not qualify if:

• B-HCG levels more or equal to 5000
• Hemoglobin level less than 10 g/dl Platelet level less than 100,000
• Increasing the level of liver function tests and the level of urea and creatinine The presence of fetal heart activity in the gestational sac

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam Khomeini Hospital Complex

Tehran, Iran

Location

Related Publications (1)

• Tarafdari A, Eslami Khotbesara S, Keikha F, Parsaei M, Poorabdoli M, Chill HH, Hadizadeh A. Comparing the effectiveness of letrozole versus methotrexate for treatment of ectopic pregnancy: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2024 Aug;299:219-224. doi: 10.1016/j.ejogrb.2024.06.026. Epub 2024 Jun 17.

  PMID: 38901084 DERIVED

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Letrozole; Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• azadeh tarafdari

  Tehran University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: June 26, 2023
• Study Start: January 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: December 20, 2024
• Last Updated: March 26, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)