DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

Dexa Medica

Status and phase: Completed; Phase 3; Phase 2

Conditions: Visual Analogue Pain Scale: Moderate or Severe Pain; Endometrioma

Treatments: Drug: Mefenamic acid; Drug: DLBS1442 100; Drug: DLBS1442 200

Study type: Interventional

Funder types: Industry

Identifiers

NCT01942122

DLBS1442-0212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

DLBS1442 100

Experimental group

Description:

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

Treatment:

Drug: DLBS1442 100

DLBS1442 200

Experimental group

Description:

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

Treatment:

Drug: DLBS1442 200

Mefenamic acid

Active Comparator group

Description:

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.

Treatment:

Drug: Mefenamic acid