Status:
COMPLETED
Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery
Lead Sponsor:
Universitas Diponegoro
Conditions:
Endometriosis Ovary
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question\[s\] it aims to answer are: 1. Health-related quality of life ...
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 Pro...
Eligibility Criteria
Inclusion
- Patient post surgical removal of endometriosis cyst Willing to participate
Exclusion
- Use of any hormonal therapy for endometriosis within the previous 16 weeks.
- History of severe adverse drug reactions or hypersensitivity to steroid hormones.
- Failure of previous treatment with COC, DMPA used in this study.
- There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies.
- Smoker.
Key Trial Info
Start Date :
September 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06145438
Start Date
September 4 2023
End Date
November 19 2024
Last Update
December 11 2024
Active Locations (1)
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1
Kariadi Hospital
Semarang, Central Java, Indonesia, 50244