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This is a 3-arm, prospective, randomized, double-blind, and controlled study of DLBS1442 for the treatment of pain in patients suspected endometriosis. It is hypothesized that the reduction of the composite-pain intensity (as measured by VAS) from baseline to the end of study (week 8th) resulting from administration of DLBS1442, regardless of the dosage regimen, is significantly greater than that of Control. In addition, the administration of DLBS1442 at higher dose also results in significantly greater reduction than that of DLBS1442 at lower dose and of Control.
There will be three groups of treatment by dosage regimen in this study. Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1442 at a dose of 3 x 100 mg daily, or 2) DLBS1442 at a dose of 3 x 200 mg daily; or 3) mefenamic acid at a dose of 3 x 500 mg daily. DLBS1442 will be taken every day along the study period (8 weeks), while mefenamic acid will only be taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period. Study treatment will be given at a standardized starting point for all subjects, i.e. on the first day of their respective menstrual periods. Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and every 4-week interval throughout the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLBS1442 100 | Experimental | DLBS1442 capsules 3x100 mg daily, taken every day along the study period |
|
| DLBS1442 200 | Experimental | DLBS1442 capsules 3x200 mg daily, taken every day along the study period |
|
| Mefenamic acid | Active Comparator | Mefenamic acid tablets 3 x 500 mg daily, only taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS1442 100 | Drug | Study treatment will be DLBS1442 capsules at a dose of 3x100 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of intensity (VAS) of composite-pain | Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS). | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the intensity of each pain (VAS) | Reduction of the intensity of each pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS). | Week 4, week 8 |
| Response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kanadi Sumapraja, SpOG(K), MD | Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana) | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia | ||
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008528 | Mefenamic Acid |
| ID | Term |
|---|---|
| D054361 | Fenamates |
| D062367 | ortho-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
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|
| Mefenamic acid | Drug | Control will be mefenamic acid 500 mg tablets, administered 3 times daily for 5 days during the menstrual period, i.e. day 1st to day 5th of the menstrual period. The drug will be given within the 8 weeks of study period (2 menstrual cycles). |
|
|
| DLBS1442 200 | Drug | Study treatment will be DLBS1442 capsules at a dose of 3x200 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles). |
|
|
Response rate is defined as percentage of subjects at the end of study experiencing a reduction of VAS score of >= 3 or >= 30% as compared to baseline, in each of the composite pain found at baseline (i.e. dysmenorrhea, dyspareunia, non-menstrual pelvic pain, dysuria, or dyschezia).
| Week 8 |
| Improvement of quality of life | Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score. | Week 4, week 8 |
| Serum CA-125 | Reduction in serum CA-125 level. | Week 8 |
| IL-6 | Change of IL-6 | Week 8 |
| Number of rescue medication | Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study. | During the course of the study |
| Pain-free period | Time to the first day on which subjects take rescue medication. | During the course of the study |
| Percentage or proportion of subjects who complete the study | Percentage or proportion of subjects who complete the study (2 cycles). | Week 8 |
| ECG | Electrocardiography. | Week 8 |
| Vital signs | Vital signs measured include: blood pressure, heart rate, respiratory rate. | Week 4, week 8 |
| Liver function | Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP). | Week 8 |
| Renal function | Renal function measured includes: serum creatinine and blood urea nitrogen (BUN). | Week 8 |
| Routine hematology | Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count. | Week 8 |
| Adverse event | Adverse event will be observed and managed along the study course. | During the course of the study |
| Reduction of intensity (VAS) of composite-pain | Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS). | 4 weeks |
| hs-CRP | Change in serum hs-CRP. | Week 8 |
| Department of Obstetrics and Gynecology, RSUP Persahabatan |
| Jakarta Pusat |
| Jakarta Special Capital Region |
| Indonesia |
| Department of Obstetrics and Gynecology RSUP Fatmawati | Jakarta | Indonesia |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |