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

Dexa Medica Group

1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)

1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)

1 DLBS3233 capsule 100 mg once daily for 6 months

1 Metformin XR caplet 750 mg twice daily for 6 months

1 placebo caplet of Metformin XR twice daily for 6 months

Placebo caplet of Metformin XR

1 placebo capsule of DLBS3233 once daily for 6 months

Placebo capsule of DLBS3233

Andon Hestiantoro, dr., SpOG(K)

Wiryawan Permadi, Dr., dr., SpOG(K)

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.

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.

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

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

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)

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

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

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

HOMA-IR reduction from baseline to Month 3rd

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)	NCT01733459	Polycystic Ovar...	DLBS3233 Metformin XR Placebo caplet ... Placebo capsule...	18 Years - 40 Years	Dexa Medica Group

Spots Global Cancer Trial Database for dlbs3233

Every month we try and update this database with for dlbs3233 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dlbs3233

Every month we try and update this database with for dlbs3233 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dlbs3233 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.