A Phase 3 interventional study of DLBS3233 and Metformin XR in Polycystic Ovary Syndrome (PCOS) and Insulin Resistance, sponsored by Dexa Medica Group. Completed at 7 sites in Indonesia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Dexa Medica Group · Phase 3, Interventional, and Treatment
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.
There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following:
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 186 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Dexa Medica Group is the lead sponsor of 39 studies on the registry; none are open to participants now.
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Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the following (Rotterdam Criteria):
Exclusion Criteria:
Based on previous or current medical (either laboratory or clinical) examination, subjects known to have any of the following conditions:
Known to have the following medical condition:
Have been regularly taking any of the following medications, within ≤ 3 months prior to screening, such as:
DLBS3233 100 mg capsule once daily, and Placebo metformin caplet twice daily; orally, for 6 months
Drug: DLBS3233 · Drug: Placebo metformin
Metformin XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6 months
Drug: Metformin XR · Drug: Placebo DLBS3233
DLBS3233 100 mg capsule once daily, and Metformin XR 750 mg caplet twice daily; orally, for 6 months.
Drug: DLBS3233 · Drug: Metformin XR
Also known as: Inlacin
Also known as: Glumin XR
Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin).
Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).
HOMA-IR reduction
HOMA-IR reduction from baseline to Month 6th (end of study)
Time frame: 6 months
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)
Time frame: 3 and 6 months
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)
Time frame: 3 and 6 months
Change of waist circumference
1, 2, 3, 4, 5, and 6 months
Time frame: 1, 2, 3, 4, 5, and 6 months
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.
Time frame: menstrual cycle of Month 3rd up to that of Month 6th
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
Time frame: 3 to 6 months
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.
Time frame: 3 to 6 months
Improvement in Ferriman-Gallwey Score
Improvement in Ferriman-Gallwey Score from baseline to Month 3rd and Month 6th (the end of study)
Time frame: 3 and 6 months
Reduction of free testosterone level
Reduction of free testosterone level from baseline to Month 6th (end of study)
Time frame: 6 months
Change of luteinizing hormone (LH) level
Change of luteinizing hormone (LH) level from baseline to Month 6th (end of study)
Time frame: 6 months
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)
Time frame: 6 months
Liver function
Liver function (levels of serum AST, ALT, alkaline phosphatase) will be measured at baseline and Month 6th (end of study)
Time frame: 6 months
Renal function
Renal function (levels of serum creatinine, BUN) will be measured at baseline and Month 6th (end of study)
Time frame: 6 months
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
Time frame: During 6 months
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Dexa Medica Group