PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

Phase 3CompletedNCT01999686

Dexa Medica Group186 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

186

Conditions

Polycystic Ovary Syndrome (PCOS)Insulin Resistance

Interventions

DLBS3233DRUG

Metformin XRDRUG

Placebo metforminDRUG

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

Placebo DLBS3233

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (7)

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

Outcomes

Primary Outcomes

HOMA-IR reduction

HOMA-IR reduction from baseline to Month 6th (end of study)

Time frame: 6 months

Secondary Outcomes

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)

Time frame: 3 and 6 months

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)

Time frame: 3 and 6 months

Change of waist circumference

1, 2, 3, 4, 5, and 6 months

Time frame: 1, 2, 3, 4, 5, and 6 months

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.

Time frame: menstrual cycle of Month 3rd up to that of Month 6th

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

Time frame: 3 to 6 months

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.

Data from ClinicalTrials.gov

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