Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

Study Overview
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Brief Summary
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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: Health-related quality of life (HRQoL) VAS score Beta estradiol TNF Alpha Adnexal mass recurrence Participants will be randomized into 4 groups, each group will receive: Leuprolide Acetate injection/month Dienogest 2 mg/day COC (mycrogynon)/day DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.

Detailed Description
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Beta estradiol level is measured in the serum, before and after treatment TNF alpha is measured in the serum, before and after treatment Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30) VAS score will be recorded before and after treatment Adnexal massa recurrence evaluation using USG

Official Title
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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

Conditions
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Endometriosis Ovary

Intervention / Treatment
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* Drug: Dienogest
* Drug: Depo Medroxyprogesterone acetate
* Drug: Leuprolide (as Leuprolide Acetate)
* Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient post surgical removal of endometriosis cyst Willing to participate Exclusion Criteria: 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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Leuprolide Acetate<br>Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months | Drug: Leuprolide (as Leuprolide Acetate)<br>* Drug is injected intramuscularly on the buttock<br>* Other names: Tapros;|
| Experimental: Dienogest<br>Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months | Drug: Dienogest<br>* Drug is administered orally at the same time every day<br>* Other names: Nelandoz;|
| Experimental: Depot medroxyprogesterone acetate<br>Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months | Drug: Depo Medroxyprogesterone acetate<br>* Drug is injected intramuscularly on the buttock<br>* Other names: Depo Provera;|
| Experimental: Combined Oral Contraceptive<br>Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months | Drug: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)<br>* Drug is administered orally at the same time every day<br>* Other names: Combined oral contraceptive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beta estradiol level | Measuring beta estradiol level on the serum | 0 and 12 weeks of treatment | 
| TNF alpha level | Measuring TNF alpha level on the serum | 0 and 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum. 0 means no pain and 10 meansworst pain | 0 and 12 weeks of treatment | 
| health-related quality of life (HRQoL) | Endometriosis Health Profile-30 (EHP-30). It consists of 30 items to which respondents can choose between the answers: Never (0); Rarely (1), Sometimes (2); Often (3); and Always (4). The 30 items are divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. Each scale is standardized on a scale from 0 to 100, with lower scores indicating better QoL | 0 and 12 weeks of treatment | 
| Mass recurrence | Evaluate the adnexal mass using Ultrasound after completing treatment | 0 and 12 weeks of treatment |