Clinical trial NCT01733459: Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)
Official title: The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: PCOS, DLBS3233, metformin,oral anti-hyperglycemic agent
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: HOMA-IR reduction
timeFrame: 6 months
Secondary outcomes:
measure: Reduction of S/A ratio
timeFrame: 3 and 6 months
measure: Reduction of free testosterone level (calculated)
timeFrame: 6 months
measure: Change of luteinizing hormone (LH) level
timeFrame: 6 months
measure: Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio
timeFrame: 6 months
measure: Change of Ferriman-Gallwey Score
timeFrame: 3 and 6 months
measure: Improvement of glucose tolerance
timeFrame: 3 and 6 months
measure: Fasting insulin level reduction
timeFrame: 3 and 6 months
measure: HOMA-IR reduction
timeFrame: 3 months
measure: Lipid profile improvement
timeFrame: 3 and 6 months
measure: Liver function
timeFrame: 6 months
measure: Renal function
timeFrame: 6 months
measure: Number of adverse events and subjects with events
timeFrame: During 6 months
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital
state: West Java
city: Jakarta
country: Indonesia
facility: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital
Study officials:
affiliation: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
name: Andon Hestiantoro, dr., SpOG(K)
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia
name: Wiryawan Permadi, Dr., dr., SpOG(K)
role: PRINCIPAL_INVESTIGATOR
References: