Clinical trial
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
Name
00000088
Description
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.
Trial arms
Trial start
2023-09-04
Estimated PCD
2024-03-04
Trial end
2024-04-04
Status
Recruiting
Phase
Early phase I
Treatment
Dienogest
Drug is administered orally at the same time every day
Arms:
Dienogest
Other names:
Nelandoz
Depo Medroxyprogesterone acetate
Drug is injected intramuscularly on the buttock
Arms:
Depot medroxyprogesterone acetate
Other names:
Depo Provera
Leuprolide (as Leuprolide Acetate)
Drug is injected intramuscularly on the buttock
Arms:
Leuprolide Acetate
Other names:
Tapros
Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)
Drug is administered orally at the same time every day
Arms:
Combined Oral Contraceptive
Other names:
Combined oral contraceptive
Size
100
Primary endpoint
beta estradiol level
0 and 12 weeks of treatment
TNF alpha level
0 and 12 weeks of treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-11-24
1 organization
4 products
1 indication
Organization
Universitas DiponegoroProduct
DienogestIndication
EndometriosisProduct
Depo MedroxyprogesteroneProduct
Leuprolide