Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery
- Conditions
- Endometriosis Ovary
- Interventions
- Registration Number
- NCT06145438
- Lead Sponsor
- Universitas Diponegoro
- 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 (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 injection/month
2. Dienogest 2 mg/day
3. COC (mycrogynon)/day
4. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Patient post surgical removal of endometriosis cyst Willing to participate
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Leuprolide Acetate Leuprolide (as Leuprolide Acetate) Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months Dienogest Dienogest Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months Depot medroxyprogesterone acetate Depo Medroxyprogesterone acetate Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months Combined Oral Contraceptive Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon) Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months
- Primary Outcome Measures
Name Time Method beta estradiol level 0 and 12 weeks of treatment Measuring beta estradiol level on the serum
TNF alpha level 0 and 12 weeks of treatment Measuring TNF alpha level on the serum
- Secondary Outcome Measures
Name Time Method Mass recurrence 0 and 12 weeks of treatment Evaluate the adnexal mass using Ultrasound after completing treatment
VAS score 0 and 12 weeks of treatment Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum. 0 means "no pain" and 10 means"worst pain
health-related quality of life (HRQoL) 0 and 12 weeks of treatment 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
Trial Locations
- Locations (1)
Kariadi Hospital
🇮🇩Semarang, Central Java, Indonesia