The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
18 Years
40 Years
Female
Polycystic Ovary Syndrome (PCOS)
Trial Information
The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
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.
Inclusion Criteria:
- Female subjects in reproductive age (i.e. 18-40 years)
- Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the
Rotterdam Criteria
- Subject with insulin resistance defined by: HOMA-IR of > 2.00
Exclusion Criteria:
- Pregnant and lactating women
- Subjects known to have Cushing's syndrome, late onset of congenital adrenal
hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease,
hyperprolactinemia
- Known to have current medical condition, which, is judged by the Investigator could
jeopardize subject's health or interfere with the study evaluation, such as diabetes
mellitus, uncontrolled hypertension, other cardiovascular diseases, acute or chronic
infections, and any known malignancies
- Impaired renal function (serum creatinine level > 1.5 ULN)
- Impaired liver function (serum ALT level ≥ 2.5 ULN)
- 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 medications which affect insulin sensitivity as well
as reproductive function (i.e. ovulation, menstrual cycle), within ≤ 3 months prior
to screening
- Participating in other clinical trial within 30 days prior to screening
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
HOMA-IR reduction
Outcome Description:
HOMA-IR reduction from baseline to Month 6th (end of study)
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Andon Hestiantoro, dr., SpOG(K)
Investigator Role:
Principal Investigator
Investigator Affiliation:
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Authority:
Indonesia: National Agency of Drug and Food Control
Study ID:
DLBS3233-0811
NCT ID:
NCT01733459
Start Date:
March 2013
Completion Date:
August 2014
Related Keywords:
- Polycystic Ovary Syndrome (PCOS)
- Polycystic ovary syndrome, DLBS3233, metformin, oral anti-hyperglycemic agent
- Polycystic Ovary Syndrome
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