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

Primary Purpose

Polycystic Ovary Syndrome (PCOS)

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
DLBS3233
Metformin XR
Placebo caplet of Metformin XR
Placebo capsule of DLBS3233
Sponsored by
Dexa Medica Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring PCOS, DLBS3233, metformin,oral anti-hyperglycemic agent

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment I

Treatment II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction of S/A ratio
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)
Reduction of free testosterone level (calculated)
Reduction of free testosterone level (calculated) from baseline to Month 6th (end of study)
Change of luteinizing hormone (LH) level
Change of luteinizing hormone (LH) level from baseline to Month 6th (end of study)
Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio
Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio from baseline to Month 6th (end of study)
Change of Ferriman-Gallwey Score
Change of Ferriman-Gallwey Score from baseline to Month 3rd and Month 6th (end of study)
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)
Fasting insulin level reduction
Fasting insulin level reduction from baseline to Month 3rd and Month 6th (end of study)
HOMA-IR reduction
HOMA-IR reduction from baseline to Month 3rd
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)
Liver function
Liver function (serum AST, ALT, alkaline phosphatase, γ-glutamyl transferase) from baseline to Month 6th (end of study)
Renal function
Renal function (serum creatinine, BUN) from baseline to Month 6th (end of study)
Number of adverse events and subjects with events
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

Full Information

First Posted
November 21, 2012
Last Updated
July 24, 2018
Sponsor
Dexa Medica Group
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1. Study Identification

Unique Protocol Identification Number
NCT01733459
Brief Title
Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)
Official Title
The Role of DLBS3233 in the Management of Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dexa Medica Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome (PCOS)
Keywords
PCOS, DLBS3233, metformin,oral anti-hyperglycemic agent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment I
Arm Type
Experimental
Arm Description
1 DLBS3233 capsule 100 mg (once daily) and 1 placebo caplet of Metformin XR (twice daily)
Arm Title
Treatment II
Arm Type
Active Comparator
Arm Description
1 Metformin XR caplet 750 mg (twice daily) and 1 placebo capsule of DLBS3233 (once daily)
Intervention Type
Drug
Intervention Name(s)
DLBS3233
Other Intervention Name(s)
Inlacin
Intervention Description
1 DLBS3233 capsule 100 mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Metformin XR
Other Intervention Name(s)
Glumin XR
Intervention Description
1 Metformin XR caplet 750 mg twice daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo caplet of Metformin XR
Other Intervention Name(s)
Placebo caplet of Glumin XR
Intervention Description
1 placebo caplet of Metformin XR twice daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo capsule of DLBS3233
Other Intervention Name(s)
Placebo capsule of Inlacin
Intervention Description
1 placebo capsule of DLBS3233 once daily for 6 months
Primary Outcome Measure Information:
Title
HOMA-IR reduction
Description
HOMA-IR reduction from baseline to Month 6th (end of study)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction of S/A ratio
Description
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)
Time Frame
3 and 6 months
Title
Reduction of free testosterone level (calculated)
Description
Reduction of free testosterone level (calculated) from baseline to Month 6th (end of study)
Time Frame
6 months
Title
Change of luteinizing hormone (LH) level
Description
Change of luteinizing hormone (LH) level from baseline to Month 6th (end of study)
Time Frame
6 months
Title
Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio
Description
Change of luteinizing hormone (LH) / follicle stimulating hormone (FSH) ratio from baseline to Month 6th (end of study)
Time Frame
6 months
Title
Change of Ferriman-Gallwey Score
Description
Change of Ferriman-Gallwey Score from baseline to Month 3rd and Month 6th (end of study)
Time Frame
3 and 6 months
Title
Improvement of glucose tolerance
Description
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
Title
Fasting insulin level reduction
Description
Fasting insulin level reduction from baseline to Month 3rd and Month 6th (end of study)
Time Frame
3 and 6 months
Title
HOMA-IR reduction
Description
HOMA-IR reduction from baseline to Month 3rd
Time Frame
3 months
Title
Lipid profile improvement
Description
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
Title
Liver function
Description
Liver function (serum AST, ALT, alkaline phosphatase, γ-glutamyl transferase) from baseline to Month 6th (end of study)
Time Frame
6 months
Title
Renal function
Description
Renal function (serum creatinine, BUN) from baseline to Month 6th (end of study)
Time Frame
6 months
Title
Number of adverse events and subjects with events
Description
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
Time Frame
During 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andon Hestiantoro, dr., SpOG(K)
Organizational Affiliation
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wiryawan Permadi, Dr., dr., SpOG(K)
Organizational Affiliation
Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital, Bandung, Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia
Facility Name
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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