DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Phase 2

Completed

• Conditions: Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain
• Interventions: Drug: DLBS1442 200; Drug: DLBS1442 100; Drug: Mefenamic acid

• Registration Number: NCT01942122
• Lead Sponsor: Dexa Medica Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Study Start: 2015-10
• Primary Completion: 2021-02
• Study Completion: 2021-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DLBS1442 200	DLBS1442 200	DLBS1442 capsules 3x200 mg daily, taken every day along the study period
DLBS1442 100	DLBS1442 100	DLBS1442 capsules 3x100 mg daily, taken every day along the study period
Mefenamic acid	Mefenamic acid	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.

Primary Outcome Measures

Name	Time	Method
Reduction of intensity (VAS) of composite-pain	Week 8	Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Vital signs	Week 4, week 8	Vital signs measured include: blood pressure, heart rate, respiratory rate.
IL-6	Week 8	Change of IL-6
Routine hematology	Week 8	Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
Reduction of the intensity of each pain (VAS)	Week 4, week 8	Reduction of the intensity of each pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Improvement of quality of life	Week 4, week 8	Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.
Serum CA-125	Week 8	Reduction in serum CA-125 level.
Number of rescue medication	During the course of the study	Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study.
Pain-free period	During the course of the study	Time to the first day on which subjects take rescue medication.
Percentage or proportion of subjects who complete the study	Week 8	Percentage or proportion of subjects who complete the study (2 cycles).
hs-CRP	Week 8	Change in serum hs-CRP.
Response rate	Week 8	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).
Adverse event	During the course of the study	Adverse event will be observed and managed along the study course.
ECG	Week 8	Electrocardiography.
Reduction of intensity (VAS) of composite-pain	4 weeks	Reduction of the intensity of composite-pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).
Liver function	Week 8	Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).
Renal function	Week 8	Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).

Trial Locations

Locations (3)

Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana); 🇮🇩 Jakarta Pusat, Jakarta, Indonesia

Department of Obstetrics and Gynecology, RSUP Persahabatan; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia

Department of Obstetrics and Gynecology RSUP Fatmawati; 🇮🇩 Jakarta, Indonesia