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  • STATUS
    Recruiting
  • participants needed
    186
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Updated on 28 September 2022
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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.

Details
Condition Polycystic Ovarian Syndrome(PCOS), Insulin Resistance
Age 18years - 40years
Clinical Study IdentifierNCT01995464
Last Modified on28 September 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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)
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

Exclusion Criteria

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 tumours, uncontrolled thyroid disease, hyperprolactinemia
Known to have the following medical condition
Diabetes mellitus
Uncontrolled hypertension
Symptomatic cardiovascular diseases
Acute or chronic infections at baseline
Any known malignancies
History of gynaecological 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 thiazolidinedione's
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
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