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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01999686
Other study ID # DLBS3233-1013
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2014
Est. completion date May 2019

Study information

Verified date May 2019
Source Dexa Medica Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date May 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

1. Signed written informed consent prior to participation in the study.

2. Female subjects in reproductive age (i.e. 18-40 years) willing to conceive.

3. 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).

4. Subject with insulin resistance defined by : HOMA-IR of > 2.00.

5. Subject with body mass index (BMI) of 19-35 inclusive.

6. Able to take oral medication.

Exclusion Criteria:

1. Pregnant or lactating women (urinary pregnancy test will be applied at screening).

2. 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.

3. Known to have the following medical condition:

- Diabetes mellitus,

- Uncontrolled hypertension

- Symptomatic cardiovascular diseases:

- Acute or chronic infections at baseline.

- Any known malignancies.

4. History of gynecological surgery.

5. Impaired renal function

6. Impaired liver function

7. Medically-assisted weight loss with medications or surgical procedures.

8. Currently having laparoscopic ovarian diathermy (LOD).

9. Currently under treatment with in vitro fertilization (IVF) techniques.

10. 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

11. Participating in other clinical trial within 30 days prior to screening.

Study Design


Intervention

Drug:
DLBS3233

Metformin XR

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

Locations

Country Name City State
Indonesia Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Lambung Mangkurat, Ulin Banjarmasin Hospital Banjarmasin
Indonesia Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Udayana, Sanglah Hospital Denpasar
Indonesia Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Hasanuddin, Dr. Wahidin Sudirohusodo Hospital Makasar
Indonesia Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Brawijaya, Dr. Saiful Anwar Hospital Malang
Indonesia Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Sam Ratulangi, Prof. Dr. Kandou Hospital Manado
Indonesia Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital Semarang
Indonesia Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital. Surabaya

Sponsors (1)

Lead Sponsor Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary HOMA-IR reduction HOMA-IR reduction from baseline to Month 6th (end of study) 6 months
Secondary 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) 3 and 6 months
Secondary 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) 3 and 6 months
Secondary Change of waist circumference 1, 2, 3, 4, 5, and 6 months 1, 2, 3, 4, 5, and 6 months
Secondary 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. menstrual cycle of Month 3rd up to that of Month 6th
Secondary 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 3 to 6 months
Secondary 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. 3 to 6 months
Secondary Improvement in Ferriman-Gallwey Score Improvement in Ferriman-Gallwey Score from baseline to Month 3rd and Month 6th (the end of study) 3 and 6 months
Secondary Reduction of free testosterone level Reduction of free testosterone level from baseline to Month 6th (end of study) 6 months
Secondary Change of luteinizing hormone (LH) level Change of luteinizing hormone (LH) level from baseline to Month 6th (end of study) 6 months
Secondary 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) 6 months
Secondary Liver function Liver function (levels of serum AST, ALT, alkaline phosphatase) will be measured at baseline and Month 6th (end of study) 6 months
Secondary Renal function Renal function (levels of serum creatinine, BUN) will be measured at baseline and Month 6th (end of study) 6 months
Secondary 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 During 6 months
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