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
Overview
- Phase
- Phase 3
- Intervention
- Leuprolide (as Leuprolide Acetate)
- Conditions
- Endometriosis Ovary
- Sponsor
- Universitas Diponegoro
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- beta estradiol level
- Status
- Completed
- Last Updated
- last year
Overview
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:
- 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
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
Investigators
Yuli Trisetiyono
Principal Investigator
Universitas Diponegoro
Eligibility Criteria
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.
Arms & Interventions
Leuprolide Acetate
Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months
Intervention: Leuprolide (as Leuprolide Acetate)
Dienogest
Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months
Intervention: Dienogest
Depot medroxyprogesterone acetate
Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months
Intervention: Depo Medroxyprogesterone acetate
Combined Oral Contraceptive
Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months
Intervention: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)
Outcomes
Primary Outcomes
beta estradiol level
Time Frame: 0 and 12 weeks of treatment
Measuring beta estradiol level on the serum
TNF alpha level
Time Frame: 0 and 12 weeks of treatment
Measuring TNF alpha level on the serum
Secondary Outcomes
- Mass recurrence(0 and 12 weeks of treatment)
- VAS score(0 and 12 weeks of treatment)
- health-related quality of life (HRQoL)(0 and 12 weeks of treatment)