Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145438
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-10-22
Brief Title:
Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery
Sponsor:
Universitas Diponegoro
Organization:
Universitas Diponegoro
Study Overview
Official Title:
Comparing the Safety and Efficacy in the Use of Dienogest Leuprolide Acetate DMPA and Combined Oral Contraceptive Pills Microgynon on Endometriosis Patients After Conservative Surgery
Status:
RECRUITING
Status Verified Date:
2023-11
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:
ENDOSafe
Brief Summary:
The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery The main questions it aims to answer are
1 Health-related quality of life HRQoL
2 VAS score
3 Beta estradiol
4 TNF Alpha
5 Adnexal mass recurrence
Participants will be randomized into 4 groups each group will receive
1 Leuprolide Acetate injectionmonth
2 Dienogest 2 mgday
3 COC mycrogynonday
4 DMPA injection 150mgmonth Researcher will compare the efficacy and safety in the assigned group
1 Health-related quality of life HRQoL
2 VAS score
3 Beta estradiol
4 TNF Alpha
5 Adnexal mass recurrence
Participants will be randomized into 4 groups each group will receive
1 Leuprolide Acetate injectionmonth
2 Dienogest 2 mgday
3 COC mycrogynonday
4 DMPA injection 150mgmonth Researcher will compare the efficacy and safety in the assigned group
Detailed Description:
1 Beta estradiol level is measured in the serum before and after treatment
2 TNF alpha is measured in the serum before and after treatment
3 Evaluation of HRQoL using the Endometriosis Health Profile-30 EHP-30
4 VAS score will be recorded before and after treatment
5 Adnexal massa recurrence evaluation using USG
2 TNF alpha is measured in the serum before and after treatment
3 Evaluation of HRQoL using the Endometriosis Health Profile-30 EHP-30
4 VAS score will be recorded before and after treatment
5 Adnexal massa recurrence evaluation using USG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None