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

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ClinicalTrials.gov Identifier: NCT01733459
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome (PCOS) Drug: DLBS3233 Drug: Metformin XR Drug: Placebo caplet of Metformin XR Drug: Placebo capsule of DLBS3233 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
Study Start Date : March 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment I
1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
 Drug: DLBS3233
1 DLBS3233 capsule 100 mg once daily for 6 months
Other Name: Inlacin

Drug: Placebo caplet of Metformin XR
1 placebo caplet of Metformin XR twice daily for 6 months
Other Name: Placebo caplet of Glumin XR
Active Comparator: Treatment II
1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)
 Drug: Metformin XR
1 Metformin XR caplet 750 mg twice daily for 6 months
Other Name: Glumin XR

Drug: Placebo capsule of DLBS3233
1 placebo capsule of DLBS3233 once daily for 6 months
Other Name: Placebo capsule of Inlacin


Outcome Measures
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Primary Outcome Measures :
  1. HOMA-IR reduction [ Time Frame: 6 months ]
    HOMA-IR reduction from baseline to Month 6th (end of study)


Secondary Outcome Measures :
  1. Reduction of S/A ratio [ Time Frame: 3 and 6 months ]
    Reduction (indicating improvement) of S/A ratio (i.e. ratio of mean stromal echogenicity to mean echogenicity of entire ovary) from baseline to Month 3rd and Month 6th (end of study)

  2. Reduction of free testosterone level (calculated) [ Time Frame: 6 months ]
    Reduction of free testosterone level (calculated) from baseline to Month 6th (end of study)

  3. Change of luteinizing hormone (LH) level [ Time Frame: 6 months ]
    Change of luteinizing hormone (LH) level from baseline to Month 6th (end of study)

  4. Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio [ Time Frame: 6 months ]
    Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio from baseline to Month 6th (end of study)

  5. Change of Ferriman-Gallwey Score [ Time Frame: 3 and 6 months ]
    Change of Ferriman-Gallwey Score from baseline to Month 3rd and Month 6th (end of study)

  6. Improvement of glucose tolerance [ Time Frame: 3 and 6 months ]
    Improvement of glucose tolerance (reduction of FPG and 2-hour PPPG) from baseline to Month 3rd and Month 6th (end of study)

  7. Fasting insulin level reduction [ Time Frame: 3 and 6 months ]
    Fasting insulin level reduction from baseline to Month 3rd and Month 6th (end of study)

  8. HOMA-IR reduction [ Time Frame: 3 months ]
    HOMA-IR reduction from baseline to Month 3rd

  9. Lipid profile improvement [ Time Frame: 3 and 6 months ]
    Lipid profile improvement (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides level) from baseline to Month 3rd and Month 6th (end of study)

  10. Liver function [ Time Frame: 6 months ]
    Liver function (serum AST, ALT, alkaline phosphatase, γ-glutamyl transferase) from baseline to Month 6th (end of study)

  11. Renal function [ Time Frame: 6 months ]
    Renal function (serum creatinine, BUN) from baseline to Month 6th (end of study)

  12. Number of adverse events and subjects with events [ Time Frame: During 6 months ]
    Adverse events as well as number of events and subjects experiencing the events will be observed and evaluated throughout study period (6 months) and until all adverse events have been recovered or stabilized


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733459


Locations
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Indonesia
Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital
Bandung, West Java, Indonesia, 40161
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Dexa Medica Group
Investigators
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Principal Investigator: 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
More Information
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Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01733459    
Other Study ID Numbers: DLBS3233-0811
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Keywords provided by Dexa Medica Group:
PCOS, DLBS3233, metformin,oral anti-hyperglycemic agent
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
 Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs