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

NCT01733459 | Completed Phase 3

• 1 other identifier: DLBS3233-0811
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

PCOS, DLBS3233, metformin,oral anti-hyperglycemic agent

Outcome Measures

Primary Outcomes (1)

• HOMA-IR reduction

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

  6 months

Secondary Outcomes (12)

• Reduction of S/A ratio

  3 and 6 months

• Reduction of free testosterone level (calculated)

  6 months

• Change of luteinizing hormone (LH) level

  6 months

• Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio

  6 months

• Change of Ferriman-Gallwey Score

  3 and 6 months

Study Arms (2)

Treatment I

EXPERIMENTAL

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

Drug: DLBS3233; Drug: Placebo caplet of Metformin XR

Treatment II

ACTIVE COMPARATOR

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

Drug: Metformin XR; Drug: Placebo capsule of DLBS3233

Interventions

DLBS3233 DRUG

1 DLBS3233 capsule 100 mg once daily for 6 months

Also known as: Inlacin

Treatment I

Metformin XR DRUG

1 Metformin XR caplet 750 mg twice daily for 6 months

Also known as: Glumin XR

Treatment II

Placebo caplet of Metformin XR DRUG

1 placebo caplet of Metformin XR twice daily for 6 months

Also known as: Placebo caplet of Glumin XR

Treatment I

Placebo capsule of DLBS3233 DRUG

1 placebo capsule of DLBS3233 once daily for 6 months

Also known as: Placebo capsule of Inlacin

Treatment II

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (2)

Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital

Jakarta, 10430, Indonesia

Location

Related Publications (1)

• Hestiantoro A, Permadi W, Tjandrawinata RR, Wiweko B, Ritonga MA, Ferrina AI, Sumapraja K, Muharam R, Djuwantono T. The Efficacy and Safety of DLBS3233, A Combined Bioactive Fraction of Cinnamomum burmanii and Lagerstroemia speciosa Plants on The Endocrine-Metabolic Profile of Women with Polycystic Ovary Syndrome: A Randomized Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):35-47. doi: 10.22074/ijfs.2023.551350.1283.

  PMID: 39033369 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

DLBS3233

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Andon Hestiantoro, dr., SpOG(K)

  Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

  PRINCIPAL INVESTIGATOR

• Wiryawan Permadi, Dr., dr., SpOG(K)

  Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: March 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

ID (2)