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Polycystic Ovary Syndrome (PCOS)Phase 3NCT01733459

Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)

A Phase 3 study testing DLBS3233 and Metformin XR in people with Polycystic Ovary Syndrome (PCOS), run by Dexa Medica Group at 2 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 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Polycystic Ovary Syndrome (PCOS)
What is being tested?
DLBS3233 and Metformin XR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
2 sitesIndonesia
Study dates
Mar 2013to Jun 2018
Phase
Phase 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 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female subjects in reproductive age (i.e. 18-40 years)
  • Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the Rotterdam Criteria
  • Subject with insulin resistance defined by: HOMA-IR of > 2.00

Who cannot join

  • Pregnant and lactating women
  • Subjects known to have Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia
  • Known to have current medical condition, which, is judged by the Investigator could jeopardize subject's health or interfere with the study evaluation, such as diabetes mellitus, uncontrolled hypertension, other cardiovascular diseases, acute or chronic infections, and any known malignancies
  • Impaired renal function (serum creatinine level > 1.5 ULN)
  • Impaired liver function (serum ALT level ≥ 2.5 ULN)
  • Medically-assisted weight loss with medications or surgical procedures
Show all 10Show fewer
  • Currently having laparoscopic ovarian diathermy (LOD)
  • Currently under treatment with in vitro fertilization (IVF) techniques
  • Have been regularly taking any medications which affect insulin sensitivity as well as reproductive function (i.e. ovulation, menstrual cycle), within ≤ 3 months prior to screening
  • Participating in other clinical trial within 30 days prior to screening

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital

    Bandung, West Java, 40161

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

    Jakarta, 10430

Other trials in Indonesia

About this study

Official title: The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)

This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate the safety of DLBS3233 in women with polycystic ovary syndrome compared with metformin, as an active control.

Read the detailed description

There will be 2 groups of treatment; each group will consist of 62 subjects with the treatment regimens :

  • Treatment I : 1 capsule of DLBS3233 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
  • Treatment II : 1 caplet of Metformin XR 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily) for 6 months of treatment.

Clinical examination to evaluate the efficacy of the investigational drug will be performed at baseline and every interval of 1 month.

Laboratory examinations to evaluate the metabolic efficacy parameters and ultrasonography (USG) examination will be performed at baseline, Month 3rd, and end of study (Month 6th). In addition to that, USG will also be performed about 2 weeks after Month 3rd (Month 3.5th) and after Month 5th (Month 5.5th).

Laboratory examinations to evaluate the reproductive efficacy parameters (reproductive hormone levels) and safety, at baseline and Month 6th (end of study).

General counseling on lifestyle modification will be provided to the subjects by the assigned Nutritionist. All study subjects should follow a lifestyle modification. Evaluation on subjects' performance on lifestyle modification will be conducted every follow-up visit by Investigator, but particularly at baseline, Month 3rd, and end of study (Month 6th) by the Nutritionist.

Being tested
DLBS3233, Metformin XR, Placebo caplet of Metformin XR, Placebo capsule of DLBS3233
Keywords
PCOS, DLBS3233, metformin,oral anti-hyperglycemic agent
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

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

  • DLBS3233Drug

    Also called Inlacin

    1 DLBS3233 capsule 100 mg once daily for 6 months

  • Metformin XRDrug

    Also called Glumin XR

    1 Metformin XR caplet 750 mg twice daily for 6 months

  • Placebo caplet of Metformin XRDrug

    Also called Placebo caplet of Glumin XR

    1 placebo caplet of Metformin XR twice daily for 6 months

  • Placebo capsule of DLBS3233Drug

    Also called Placebo capsule of Inlacin

    1 placebo capsule of DLBS3233 once daily for 6 months

Study groups in NCT01733459
Study groupRoleWhat they receive
Treatment IExperimental1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
Receives: Drug: DLBS3233; Drug: Placebo caplet of Metformin XR
Treatment IIActive comparator1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)
Receives: Drug: Metformin XR; Drug: Placebo capsule of DLBS3233

What is being measured

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

  1. HOMA-IR reduction

    HOMA-IR reduction from baseline to Month 6th (end of study)

    Measured: 6 months

Secondary outcomes (12)

  1. Reduction of S/A ratio

    Reduction (indicating improvement) of S/A ratio (i.e. ratio of mean stromal echogenicity to mean echogenicity of entire ovary) from baseline to Month 3rd and Month 6th (end of study)

    Measured: 3 and 6 months

  2. Reduction of free testosterone level (calculated)

    Reduction of free testosterone level (calculated) from baseline to Month 6th (end of study)

    Measured: 6 months

  3. Change of luteinizing hormone (LH) level

    Change of luteinizing hormone (LH) level from baseline to Month 6th (end of study)

    Measured: 6 months

  4. Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio

    Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio from baseline to Month 6th (end of study)

    Measured: 6 months

  5. Change of Ferriman-Gallwey Score

    Change of Ferriman-Gallwey Score from baseline to Month 3rd and Month 6th (end of study)

    Measured: 3 and 6 months

  6. Improvement of glucose tolerance

    Improvement of glucose tolerance (reduction of FPG and 2-hour PPPG) from baseline to Month 3rd and Month 6th (end of study)

    Measured: 3 and 6 months

  7. Fasting insulin level reduction

    Fasting insulin level reduction from baseline to Month 3rd and Month 6th (end of study)

    Measured: 3 and 6 months

  8. HOMA-IR reduction

    HOMA-IR reduction from baseline to Month 3rd

    Measured: 3 months

  9. Lipid profile improvement

    Lipid profile improvement (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides level) from baseline to Month 3rd and Month 6th (end of study)

    Measured: 3 and 6 months

  10. Liver function

    Liver function (serum AST, ALT, alkaline phosphatase, γ-glutamyl transferase) from baseline to Month 6th (end of study)

    Measured: 6 months

  11. Renal function

    Renal function (serum creatinine, BUN) from baseline to Month 6th (end of study)

    Measured: 6 months

  12. Number of adverse events and subjects with events

    Adverse events as well as number of events and subjects experiencing the events will be observed and evaluated throughout study period (6 months) and until all adverse events have been recovered or stabilized

    Measured: During 6 months

Timeline

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

  1. First posted27 Nov 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2018
  4. Study completionJun 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01733459
Sponsor's protocol ID
DLBS3233-0811
Status last verified
Jul 2018
First submitted
21 Nov 2012
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
No

Publications

  • Hestiantoro A, Permadi W, Tjandrawinata RR, Wiweko B, Ritonga MA, Ferrina AI, Sumapraja K, Muharam R, Djuwantono T. The Efficacy and Safety of DLBS3233, A Combined Bioactive Fraction of Cinnamomum burmanii and Lagerstroemia speciosa Plants on The Endocrine-Metabolic Profile of Women with Polycystic Ovary Syndrome: A Randomized Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):35-47. doi: 10.22074/ijfs.2023.551350.1283.

    PubMed 39033369

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DLBS3233 and Metformin XR in people with Polycystic Ovary Syndrome (PCOS), run by Dexa Medica Group at 2 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 3 inclusion and 10 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 phase mean?

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?

HOMA-IR reduction (time frame: 6 months). 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 NCT01733459, which also lists 1 linked publication.

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 26 Jul 2018.

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