Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525155
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Effect GnRH Agonist Administration in Endometriosis Cyst Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of GnRH Agonist Administration on Decreasing VAS Estradiol and Anti Mullerian Hormone in Endometriosis Cyst Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Endometriosis is a chronic disease that affects 10-15 of women of childbearing age The most common symptom is pelvic pain One of the treatment options that has been proven effective in treating endometriosis symptoms including endometriosis pain is triptorelin Triptorelin has also received a distribution permit in Indonesia for the treatment of endometriosis
However patient compliance in using this drug is very low due to high medical costs and side effects of the drug Standard treatment with triptorelin is generally given every 4 weeks A previous preliminary study showed that triptorelin could be given at 6-week interval and provided treatment results that were no different from those at 4-week interval This is certainly better because with longer interval doses it can reduce medical costs reduce side effects due to hormone suppression and can increase patient compliance in undergoing treatment Therefore in this study triptorelin will be given to 2 groups and observed for 18 weeks The first group will be given triptorelin twice before surgery each with an interval of 6 weeks at baseline and week-6 Then triptorelin will be given again once after surgery at week-12 In the second group triptorelin will be given once after surgery at week-12 In this study the effect of triptorelin on the treatment of endometriosis will be measured based on the improvement in the degree of pain felt by the subjects using a visual analogue scale VAS at baseline week-6 week-12 prior to surgery and week-18 Anti Mullerian Hormone AMH levels and estradiol levels before triptorelin administration at baseline and prior to surgery week-12 The condition of the uterus and cysts will also be evaluated at the time of surgery
However patient compliance in using this drug is very low due to high medical costs and side effects of the drug Standard treatment with triptorelin is generally given every 4 weeks A previous preliminary study showed that triptorelin could be given at 6-week interval and provided treatment results that were no different from those at 4-week interval This is certainly better because with longer interval doses it can reduce medical costs reduce side effects due to hormone suppression and can increase patient compliance in undergoing treatment Therefore in this study triptorelin will be given to 2 groups and observed for 18 weeks The first group will be given triptorelin twice before surgery each with an interval of 6 weeks at baseline and week-6 Then triptorelin will be given again once after surgery at week-12 In the second group triptorelin will be given once after surgery at week-12 In this study the effect of triptorelin on the treatment of endometriosis will be measured based on the improvement in the degree of pain felt by the subjects using a visual analogue scale VAS at baseline week-6 week-12 prior to surgery and week-18 Anti Mullerian Hormone AMH levels and estradiol levels before triptorelin administration at baseline and prior to surgery week-12 The condition of the uterus and cysts will also be evaluated at the time of surgery
Detailed Description:
There will be 2 groups of treatment each group will consist of 16 subjects with study period for 18 weeks
Treatment I twice before surgery baseline and week-6 and once after surgery at week-12 Treatment II once after surgery at week-12
The eligible subjects will be allocated to receive study medication Treatment 1 or Treatment 2 in an open label study They will be asked to come to the hospital every 6-week interval throughout the study period
Subjects will be evaluated based on the improvement in the degree of pain felt by the subjects using a visual analogue scale VAS on each visit throughout the study period at baseline week-6 week-12 prior to surgery and week-18 and Anti Mullerian Hormone AMH levels and estradiol levels at baseline and week-12 prior to surgery The condition of the uterus and cysts will also be evaluated at the time of surgery at week-12
Treatment I twice before surgery baseline and week-6 and once after surgery at week-12 Treatment II once after surgery at week-12
The eligible subjects will be allocated to receive study medication Treatment 1 or Treatment 2 in an open label study They will be asked to come to the hospital every 6-week interval throughout the study period
Subjects will be evaluated based on the improvement in the degree of pain felt by the subjects using a visual analogue scale VAS on each visit throughout the study period at baseline week-6 week-12 prior to surgery and week-18 and Anti Mullerian Hormone AMH levels and estradiol levels at baseline and week-12 prior to surgery The condition of the uterus and cysts will also be evaluated at the time of surgery at week-12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None