DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

• Status: Completed
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group
• Treatments: Mefenamic Acid

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