Endometriosis Ovary
Conditions
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
Interventions
DRUGDienogest
Drug is administered orally at the same time every day
Drug is injected intramuscularly on the buttock
DRUGLeuprolide (as Leuprolide Acetate)
Drug is injected intramuscularly on the buttock
DRUGLevonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)
Drug is administered orally at the same time every day
Sponsors
Universitas Diponegoro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Patient post surgical removal of endometriosis cyst Willing to participate
Exclusion criteria
1. Use of any hormonal therapy for endometriosis within the previous 16 weeks. 2. History of severe adverse drug reactions or hypersensitivity to steroid hormones. 3. Failure of previous treatment with COC, DMPA used in this study. 4. 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. 5. Smoker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 meansworst 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 |
| Mass recurrence | 0 and 12 weeks of treatment | Evaluate the adnexal mass using Ultrasound after completing treatment |
Countries
Indonesia
Outcome results
None listed