Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05918718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-04-08
Brief Title:
Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
Assessment of the Efficacy of Letrozole in Comparison to Methotrexate in the Treatment of Ectopic Pregnancy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2 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 25 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 25 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
In the second group letrozole is given in the form of 25 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 25 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
Detailed Description:
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 mgm2 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 25 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 25 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
In the second group letrozole is given in the form of 25 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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None