Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Syndrome

Polycystic Ovary Syndrome

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Metformin

DLBS3233 100 mg capsule once daily, and Placebo metformin caplet twice daily; orally, for 6 months

Metformin XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6 months

DLBS3233 100 mg capsule once daily, and Metformin XR 750 mg caplet twice daily; orally, for 6 months.

DLBS3233

Metformin XR

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

Placebo metformin

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

Placebo DLBS3233

Soehartono Ds, Prof. dr., SpOG-K

Arsana Wiyasa IW, Dr. dr., SpOG-K

Putu Doster Mahayasa, dr., SpOG-K

Syarief Taufik, dr., SpOG-K

Nusratuddin Abdullah, Dr. dr., SpOG-K, MARS

Iwan Darma Putra, dr., SpOG-K

Eddy Suparman, Prof. Dr. dr., SpOG-K

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:

* 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.

PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

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

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

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

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

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.

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

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.

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

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

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PCOS Treatment Using DLBS3233, Metformin, and Combination of Both	NCT01999686	Polycystic Ovar... Insulin Resista...	DLBS3233 Metformin XR Placebo metform... Placebo DLBS323...	18 Years - 40 Years	Dexa Medica Group
PCOS Treatment Using DLBS3233, Metformin, and Combination of Both	NCT01999686	Polycystic Ovar... Insulin Resista...	DLBS3233 Metformin XR Placebo metform... Placebo DLBS323...	18 Years - 40 Years	Dexa Medica Group

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