AzTrials
AzTrials

Polycystic Ovary Syndrome (PCOS)Phase 3POSITIFNCT01999686

PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

A Phase 3 study testing DLBS3233 and Metformin XR in people with Polycystic Ovary Syndrome (PCOS) and Insulin Resistance, run by Dexa Medica Group at 7 sites in Indonesia.

Completed

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

Official record
Search all trials

Trial summary

This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
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
186 participants
Where
7 sitesIndonesia
Study dates
Oct 2014to May 2019
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

  • Signed written informed consent prior to participation in the study.
  • Female subjects in reproductive age (i.e. 18-40 years) willing to conceive.
  • Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the following (Rotterdam Criteria):
  • Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of ≥ 8).
  • Ovarian dysfunction indicated by menstrual irregularity: oligomenorrhea (cycles of > 35 days), or amenorrhea (no menses in the last of 3 months) after negative screening pregnancy test.
  • Polycystic ovary as shown by ultrasonography (USG).
Show all 9Show fewer
  • Subject with insulin resistance defined by : HOMA-IR of > 2.00.
  • Subject with body mass index (BMI) of 19-35 inclusive.
  • Able to take oral medication.

Who cannot join

  • Pregnant or lactating women (urinary pregnancy test will be applied at screening).
  • Based on previous or current medical (either laboratory or clinical) examination, subjects known to have any of the following conditions:
  • Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia.
  • Known to have the following medical condition:
  • Diabetes mellitus,
  • Uncontrolled hypertension
Show all 26Show fewer
  • Symptomatic cardiovascular diseases:
  • Acute or chronic infections at baseline.
  • Any known malignancies.
  • History of gynecological surgery.
  • Impaired renal function
  • Impaired liver function
  • Medically-assisted weight loss with medications or surgical procedures.
  • Currently having laparoscopic ovarian diathermy (LOD).
  • Currently under treatment with in vitro fertilization (IVF) techniques.
  • Have been regularly taking any of the following medications, within ≤ 3 months prior to screening, such as:
  • Clomiphene citrate
  • Insulin sensitizers, i.e. metformin and thiazolidinediones
  • Aromatase inhibitors, such as: anastrozole, letrozole
  • Glucocorticoids
  • Gonadotropins
  • Gonadotropin-releasing hormone agonists (GnRHa)
  • Oral contraceptive pills (OCPs)
  • Antiandrogens, such as: spironolactone, cyproterone acetate (CPA), and flutamide
  • Any traditional or herbal medicines
  • Participating in other clinical trial within 30 days prior to screening.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Indonesia7 sites

  • Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Lambung Mangkurat, Ulin Banjarmasin Hospital

    Banjarmasin

  • Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Udayana, Sanglah Hospital

    Denpasar

  • Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Hasanuddin, Dr. Wahidin Sudirohusodo Hospital

    Makasar

  • Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Brawijaya, Dr. Saiful Anwar Hospital

    Malang

  • Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Sam Ratulangi, Prof. Dr. Kandou Hospital

    Manado

  • Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital

    Semarang

  • Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital.

    Surabaya

Other trials in Indonesia

About this study

Official title: Polycystic Ovary Syndrome Treatment Using DLBS3233, Metformin, and Combination of Both, and Its Relation to Fertility

This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters.

Read the detailed description

There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following:

  • Treatment I : DLBS3233 100 mg once daily
  • Treatment II : Metformin XR 750 mg twice daily
  • Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily.

Laboratory examination to evaluate metabolic efficacy parameters will be performed at baseline, Month 3rd, and end of study (Month 6th).

Clinical and laboratory examination to evaluate the reproductive efficacy parameters using trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at baseline to the end of study.

Safety examination will be performed at baseline and end of study. Occurrence of adverse event will be observed along the study conduct.

Being tested
DLBS3233, Metformin XR, Placebo metformin, Placebo DLBS3233
Keywords
Polycystic ovarium syndrome, DLBS3233, metformin, insulin resistance, Female
Medical subject headings
Polycystic Ovary Syndrome, Insulin Resistance

What participants receive

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

  • DLBS3233Drug

    Also called Inlacin

  • Metformin XRDrug

    Also called Glumin XR

  • Placebo metforminDrug

    Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin).

  • Placebo DLBS3233Drug

    Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).

Study groups in NCT01999686
Study groupRoleWhat they receive
Treatment I : DLBS3233ExperimentalDLBS3233 100 mg capsule once daily, and Placebo metformin caplet twice daily; orally, for 6 months
Receives: Drug: DLBS3233; Drug: Placebo metformin
Treatment II : MetforminActive comparatorMetformin XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6 months
Receives: Drug: Metformin XR; Drug: Placebo DLBS3233
Treatment III : Combination DLBS3233 and MetforminExperimentalDLBS3233 100 mg capsule once daily, and Metformin XR 750 mg caplet twice daily; orally, for 6 months.
Receives: Drug: DLBS3233; Drug: Metformin XR

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 (13)

  1. 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

  2. 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

  3. Change of waist circumference

    1, 2, 3, 4, 5, and 6 months

    Measured: 1, 2, 3, 4, 5, and 6 months

  4. Response rate: presence of ovulation

    Presence of ovulation will be evaluated using trans-vaginal USG to find dominant follicle(s), at the day/period of ovulation, starting from menstrual cycle of Month 3rd up to Month 6th. Measurement of progesterone level will be performed 7 days after the finding of dominant follicle on USG examination to confirm the presence of ovulation.

    Measured: menstrual cycle of Month 3rd up to that of Month 6th

  5. Change of endometrium thickness

    Change of endometrium thickness will be measured by using trans-vaginal USG at basal condition and at the day/period of ovulation

    Measured: 3 to 6 months

  6. Improvement of S/A ratio

    Improvement from baseline of the S/A ratio (defined as the ratio between stromal and total area of median ovarian section) will be measured using trans-vaginal USG (trans-longitudinal measurement) at Baseline, menstrual cycle of Month 3rd, and menstrual cycle of Month 6th at basal condition.

    Measured: 3 to 6 months

  7. Improvement in Ferriman-Gallwey Score

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

    Measured: 3 and 6 months

  8. Reduction of free testosterone level

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

    Measured: 6 months

  9. Change of luteinizing hormone (LH) level

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

    Measured: 6 months

  10. 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

  11. Liver function

    Liver function (levels of serum AST, ALT, alkaline phosphatase) will be measured at baseline and Month 6th (end of study)

    Measured: 6 months

  12. Renal function

    Renal function (levels of serum creatinine, BUN) will be measured at baseline and Month 6th (end of study)

    Measured: 6 months

  13. 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 posted3 Dec 2013 (estimated)
  2. Study startOct 2014
  3. Primary completionFeb 2019
  4. Study completionMay 2019

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
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01999686
Sponsor's protocol ID
DLBS3233-1013
Acronym
POSITIF
Status last verified
May 2019
First submitted
26 Nov 2013
Last updated
28 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Hidayat ST, Mulyantoro I, Damas S, Tjandrawinata RR. The Effect and Safety Assessment of Metformin and DLBS3233 (A Bioactive Fraction of Lagerstroemia speciosa and Cinnamomum burmannii) on Improving Metabolic Parameters in Women with Polycystic Ovary Syndrome. Int J Womens Health. 2023 Jul 4;15:971-985. doi: 10.2147/IJWH.S409685. eCollection 2023.

    PubMed 37424700

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) and Insulin Resistance, run by Dexa Medica Group at 7 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 9 inclusion and 26 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 NCT01999686, 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 28 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in