DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

NCT ID: NCT01942122

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-04-30

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.

Conditions

Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DLBS1442 100

DLBS1442 capsules 3x100 mg daily, taken every day along the study period

Group Type: EXPERIMENTAL

DLBS1442 100

Intervention Type: 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).

DLBS1442 200

DLBS1442 capsules 3x200 mg daily, taken every day along the study period

Group Type: EXPERIMENTAL

DLBS1442 200

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Mefenamic acid

Intervention Type: 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).

Interventions

DLBS1442 100

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).

Intervention Type: DRUG

Mefenamic acid

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).

Intervention Type: DRUG

DLBS1442 200

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).

Intervention Type: DRUG

Other Intervention Names

Dismeno 100; Pondex Forte; Dismeno 200

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kanadi Sumapraja, SpOG(K), MD

Role: PRINCIPAL_INVESTIGATOR

Division of Reproductive, Endocrinology, and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital

Locations

Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Department of Obstetrics and Gynecology, RSUP Persahabatan

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Department of Obstetrics and Gynecology RSUP Fatmawati

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

DLBS1442-0212

Identifier Type: -

Identifier Source: org_study_id