Endometrioma Clinical Trial
Official title:
Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis
Verified date | January 2022 |
Source | Dexa Medica Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Signed informed consent before any trial related activities - Female of 18 - 50 years of age - Subjects suspected with cystic endometriosis or adenomyosis confirmed by transvaginal ultrasonography (or transrectal ultrasonography for unmarried subjects) - Presence of moderate or severe pain as shown by VAS score of at least 4 on at least one of the following pain: menstrual pain (dysmenorrhea), dyspareunia, non-menstrual pelvic pain, dysuria, dyschezia - Occurrence of at least 3 last sequential menstrual cycles of 21 - 35 days duration prior to screening Exclusion Criteria: - Pregnancy - Patients with infertility who are willing to be pregnant - Using hormonal contraception or other forms of hormonal therapy within the last 30 days - Being under therapy with systemic corticosteroids on a chronic or regular basis within the last 90 days - History or presence of suspected malignancy abnormalities - History of surgical treatment for endometriosis within 3 months prior to screening - History of hysterectomy or oophorectomy - Presence of clinical signs of sexually transmitted disease - Presence of unexplained uterine or cervical bleeding - Impaired liver function: serum ALT > 2.5 times upper limit of normal - Impaired renal function: serum creatinine >= 1.5 times upper limit of normal - Known or suspected allergy to similar products |
Country | Name | City | State |
---|---|---|---|
Indonesia | Department of Obstetrics and Gynecology RSUP Fatmawati | Jakarta | |
Indonesia | Department of Obstetrics and Gynecology, RSUP Persahabatan | Jakarta Pusat | Jakarta |
Indonesia | Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana) | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Response rate | 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 | |
Secondary | Improvement of quality of life | Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score. | Week 4, week 8 | |
Secondary | Serum CA-125 | Reduction in serum CA-125 level. | Week 8 | |
Secondary | IL-6 | Change of IL-6 | Week 8 | |
Secondary | 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 | |
Secondary | Pain-free period | Time to the first day on which subjects take rescue medication. | During the course of the study | |
Secondary | Percentage or proportion of subjects who complete the study | Percentage or proportion of subjects who complete the study (2 cycles). | Week 8 | |
Secondary | ECG | Electrocardiography. | Week 8 | |
Secondary | Vital signs | Vital signs measured include: blood pressure, heart rate, respiratory rate. | Week 4, week 8 | |
Secondary | Liver function | Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP). | Week 8 | |
Secondary | Renal function | Renal function measured includes: serum creatinine and blood urea nitrogen (BUN). | Week 8 | |
Secondary | Routine hematology | Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count. | Week 8 | |
Secondary | Adverse event | Adverse event will be observed and managed along the study course. | During the course of the study | |
Secondary | 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 | |
Secondary | hs-CRP | Change in serum hs-CRP. | Week 8 |
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