DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

NCT01942122 | Completed Phase 2 DMC

• 1 other identifier: DLBS1442-0212
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain

Keywords

DLBS1442; Endometriosis; Pain; Visual Analogue Scale; Endometriosis Health Profile (EHP-30TM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Reduction of the intensity of each pain (VAS)

  Week 4, week 8

• Response rate

  Week 8

• Improvement of quality of life

  Week 4, week 8

• Serum CA-125

  Week 8

• IL-6

  Week 8

Study Arms (3)

DLBS1442 100

EXPERIMENTAL

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

Drug: DLBS1442 100

DLBS1442 200

EXPERIMENTAL

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

Drug: DLBS1442 200

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.

Drug: Mefenamic acid

Interventions

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).

Also known as: Dismeno 100

DLBS1442 100

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).

Also known as: Pondex Forte

Mefenamic acid

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).

Also known as: Dismeno 200

DLBS1442 200

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (3)

Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Department of Obstetrics and Gynecology, RSUP Persahabatan

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Location

Department of Obstetrics and Gynecology RSUP Fatmawati

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Endometriosis; Pain

Interventions

Mefenamic Acid

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: October 1, 2015
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

ID (3)