Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)

Dexa Medica

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Drug: Metformin XR; Drug: Placebo caplet of Metformin XR; Drug: Placebo capsule of DLBS3233; Drug: DLBS3233

Study type: Interventional

Funder types: Industry

Identifiers

NCT01733459

DLBS3233-0811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

Treatment I

Experimental group

Description:

1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)

Treatment:

Drug: DLBS3233

Drug: Placebo caplet of Metformin XR

Treatment II

Active Comparator group

Description:

1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)

Treatment:

Drug: Placebo capsule of DLBS3233

Drug: Metformin XR