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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:
Participants will be randomized into 4 groups, each group will receive:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprolide Acetate | Active Comparator | Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months |
|
| Dienogest | Experimental | Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months |
|
| Depot medroxyprogesterone acetate | Experimental | Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months |
|
| Combined Oral Contraceptive | Experimental | Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dienogest | Drug | Drug is administered orally at the same time every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| beta estradiol level | Measuring beta estradiol level on the serum | 0 and 12 weeks of treatment |
| TNF alpha level | Measuring TNF alpha level on the serum | 0 and 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| VAS score | 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 | 0 and 12 weeks of treatment |
| health-related quality of life (HRQoL) |
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Inclusion Criteria:
Patient post surgical removal of endometriosis cyst Willing to participate
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuli Trisetiyono, SpOG (K) | Diponegoro University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kariadi Hospital | Semarang | Central Java | 50244 | Indonesia |
There is a plan to make IPD and related data dictionaries available.
Starting in March 2024
Informed Consent Form will be shared to other researchers by sending email
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| Depo Medroxyprogesterone acetate | Drug | Drug is injected intramuscularly on the buttock |
|
|
| Leuprolide (as Leuprolide Acetate) | Drug | Drug is injected intramuscularly on the buttock |
|
|
| Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon) | Drug | Drug is administered orally at the same time every day |
|
|
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
| 0 and 12 weeks of treatment |
| Mass recurrence | Evaluate the adnexal mass using Ultrasound after completing treatment | 0 and 12 weeks of treatment |
| ID | Term |
|---|---|
| C023635 | dienogest |
| D017258 | Medroxyprogesterone Acetate |
| D016729 | Leuprolide |
| D004997 | Ethinyl Estradiol |
| D003277 | Contraceptives, Oral, Combined |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
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