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EndometriomaPhase 2/3NCT01942122

DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

A Phase 2/3 study testing DLBS1442 100, Mefenamic acid and DLBS1442 200 in people with Endometrioma and Visual Analogue Pain Scale: Moderate or Severe Pain, run by Dexa Medica Group at 3 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
DLBS1442 100, Mefenamic acid and DLBS1442 200
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesIndonesia
Study dates
Oct 2015to Apr 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

3 sites in 1 country.

Indonesia3 sites

  • Department of Obstetrics and Gynecology RSUP Fatmawati

    Jakarta

  • Yasmin Clinic, Dr. Cipto Mangunkusumo Hospital (Kencana)

    Jakarta Pusat, Jakarta Special Capital Region, 10430

  • Department of Obstetrics and Gynecology, RSUP Persahabatan

    Jakarta Pusat, Jakarta Special Capital Region

Other trials in Indonesia

About this study

Official title: Role of DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis

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.

Read the 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.

Being tested
DLBS1442 100, Mefenamic acid, DLBS1442 200
Keywords
DLBS1442, Endometriosis, Pain, Visual Analogue Scale, Endometriosis Health Profile (EHP-30TM)
Medical subject headings
Endometriosis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DLBS1442 100Drug

    Also called Dismeno 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).

  • Mefenamic acidDrug

    Also called Pondex Forte

    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).

  • DLBS1442 200Drug

    Also called Dismeno 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).

Study groups in NCT01942122
Study groupRoleWhat they receive
DLBS1442 100ExperimentalDLBS1442 capsules 3x100 mg daily, taken every day along the study period
Receives: Drug: DLBS1442 100
DLBS1442 200ExperimentalDLBS1442 capsules 3x200 mg daily, taken every day along the study period
Receives: Drug: DLBS1442 200
Mefenamic acidActive comparatorMefenamic 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.
Receives: Drug: Mefenamic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 8

Secondary outcomes (16)

  1. Reduction of the intensity of each pain (VAS)

    Reduction of the intensity of each pain (dysmenorrhea, dyspareunia, non-menstrual chronic pelvic pain, dysuria, dyschezia) as measured by Visual Analogue Scale (VAS).

    Measured: Week 4, week 8

  2. Response rate

    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).

    Measured: Week 8

  3. Improvement of quality of life

    Improvement of quality of life is measured by Endometriosis Health Profile (EHP-30) questionnaire score.

    Measured: Week 4, week 8

  4. Serum CA-125

    Reduction in serum CA-125 level.

    Measured: Week 8

  5. IL-6

    Change of IL-6

    Measured: Week 8

  6. Number of rescue medication

    Number of rescue medication (pain relieving drug, i.e. ibuprofen 400 mg tablet) needed during the course of the study.

    Measured: During the course of the study

  7. Pain-free period

    Time to the first day on which subjects take rescue medication.

    Measured: During the course of the study

  8. Percentage or proportion of subjects who complete the study

    Percentage or proportion of subjects who complete the study (2 cycles).

    Measured: Week 8

  9. ECG

    Electrocardiography.

    Measured: Week 8

  10. Vital signs

    Vital signs measured include: blood pressure, heart rate, respiratory rate.

    Measured: Week 4, week 8

  11. Liver function

    Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), and alkaline phosphatase (AP).

    Measured: Week 8

  12. Renal function

    Renal function measured includes: serum creatinine and blood urea nitrogen (BUN).

    Measured: Week 8

  13. Routine hematology

    Routine hematology measured includes: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.

    Measured: Week 8

  14. Adverse event

    Adverse event will be observed and managed along the study course.

    Measured: During the course of the study

  15. 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).

    Measured: 4 weeks

  16. hs-CRP

    Change in serum hs-CRP.

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2013 (estimated)
  2. Study startOct 2015
  3. Primary completionFeb 2021
  4. Study completionApr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01942122
Sponsor's protocol ID
DLBS1442-0212
Status last verified
Jan 2022
First submitted
10 Sep 2013
Last updated
27 Jan 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing DLBS1442 100, Mefenamic acid and DLBS1442 200 in people with Endometrioma and Visual Analogue Pain Scale: Moderate or Severe Pain, run by Dexa Medica Group at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of intensity (VAS) of composite-pain (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.

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