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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group
• Treatments: Metformin

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