Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery
NCT ID: NCT06145438
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2023-09-04
2024-11-19
Brief Summary
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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
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Leuprolide Acetate
Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months
Leuprolide (as Leuprolide Acetate)
Drug is injected intramuscularly on the buttock
Dienogest
Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months
Dienogest
Drug is administered orally at the same time every day
Depot medroxyprogesterone acetate
Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months
Depo Medroxyprogesterone acetate
Drug is injected intramuscularly on the buttock
Combined Oral Contraceptive
Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months
Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)
Drug is administered orally at the same time every day
Interventions
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Dienogest
Drug is administered orally at the same time every day
Depo Medroxyprogesterone acetate
Drug is injected intramuscularly on the buttock
Leuprolide (as Leuprolide Acetate)
Drug is injected intramuscularly on the buttock
Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon)
Drug is administered orally at the same time every day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
FEMALE
No
Sponsors
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Universitas Diponegoro
OTHER
Responsible Party
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Yuli Trisetiyono
Principal Investigator
Principal Investigators
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Yuli Trisetiyono, SpOG (K)
Role: PRINCIPAL_INVESTIGATOR
Diponegoro University
Locations
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Kariadi Hospital
Semarang, Central Java, Indonesia
Countries
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Other Identifiers
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00000088
Identifier Type: -
Identifier Source: org_study_id