NCT01999686

Brief Summary

This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

4.3 years

First QC Date

November 26, 2013

Last Update Submit

May 24, 2019

Conditions

Polycystic Ovary Syndrome (PCOS)Insulin Resistance

Keywords

Polycystic ovarium syndromeDLBS3233metformininsulin resistanceFemale

Outcome Measures

Primary Outcomes (1)

  • HOMA-IR reduction

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

    6 months

Secondary Outcomes (13)

  • Lipid profile improvement

    3 and 6 months

  • Improvement of glucose tolerance

    3 and 6 months

  • Change of waist circumference

    1, 2, 3, 4, 5, and 6 months

  • Response rate: presence of ovulation

    menstrual cycle of Month 3rd up to that of Month 6th

  • Change of endometrium thickness

    3 to 6 months

  • +8 more secondary outcomes

Study Arms (3)

Treatment I : DLBS3233

EXPERIMENTAL

DLBS3233 100 mg capsule once daily, and Placebo metformin caplet twice daily; orally, for 6 months

Drug: DLBS3233Drug: Placebo metformin

Treatment II : Metformin

ACTIVE COMPARATOR

Metformin XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6 months

Drug: Metformin XRDrug: Placebo DLBS3233

Treatment III : Combination DLBS3233 and Metformin

EXPERIMENTAL

DLBS3233 100 mg capsule once daily, and Metformin XR 750 mg caplet twice daily; orally, for 6 months.

Drug: DLBS3233Drug: Metformin XR

Interventions

DLBS3233DRUG
Also known as: Inlacin
Treatment I : DLBS3233Treatment III : Combination DLBS3233 and Metformin
Metformin XRDRUG
Also known as: Glumin XR
Treatment II : MetforminTreatment III : Combination DLBS3233 and Metformin
Placebo metforminDRUG

Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin).

Treatment I : DLBS3233
Placebo DLBS3233DRUG

Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).

Treatment II : Metformin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Signed written informed consent prior to participation in the study.
  • Female subjects in reproductive age (i.e. 18-40 years) willing to conceive.
  • Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the following (Rotterdam Criteria):
  • Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of ≥ 8).
  • Ovarian dysfunction indicated by menstrual irregularity: oligomenorrhea (cycles of \> 35 days), or amenorrhea (no menses in the last of 3 months) after negative screening pregnancy test.
  • Polycystic ovary as shown by ultrasonography (USG).
  • Subject with insulin resistance defined by : HOMA-IR of \> 2.00.
  • Subject with body mass index (BMI) of 19-35 inclusive.
  • Able to take oral medication.

You may not qualify if:

  • Pregnant or lactating women (urinary pregnancy test will be applied at screening).
  • Based on previous or current medical (either laboratory or clinical) examination, subjects known to have any of the following conditions:
  • Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia.
  • Known to have the following medical condition:
  • Diabetes mellitus,
  • Uncontrolled hypertension
  • Symptomatic cardiovascular diseases:
  • Acute or chronic infections at baseline.
  • Any known malignancies.
  • History of gynecological surgery.
  • Impaired renal function
  • Impaired liver function
  • Medically-assisted weight loss with medications or surgical procedures.
  • Currently having laparoscopic ovarian diathermy (LOD).
  • Currently under treatment with in vitro fertilization (IVF) techniques.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Lambung Mangkurat, Ulin Banjarmasin Hospital

Banjarmasin, Indonesia

Location

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Udayana, Sanglah Hospital

Denpasar, Indonesia

Location

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Hasanuddin, Dr. Wahidin Sudirohusodo Hospital

Makasar, Indonesia

Location

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Brawijaya, Dr. Saiful Anwar Hospital

Malang, Indonesia

Location

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Sam Ratulangi, Prof. Dr. Kandou Hospital

Manado, Indonesia

Location

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital

Semarang, Indonesia

Location

Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital.

Surabaya, Indonesia

Location

Related Publications (1)

  • Hidayat ST, Mulyantoro I, Damas S, Tjandrawinata RR. The Effect and Safety Assessment of Metformin and DLBS3233 (A Bioactive Fraction of Lagerstroemia speciosa and Cinnamomum burmannii) on Improving Metabolic Parameters in Women with Polycystic Ovary Syndrome. Int J Womens Health. 2023 Jul 4;15:971-985. doi: 10.2147/IJWH.S409685. eCollection 2023.

    PMID: 37424700DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

DLBS3233

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Soehartono Ds, Prof. dr., SpOG-K

    Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital, Surabaya, Indonesia.

    PRINCIPAL INVESTIGATOR

  • Arsana Wiyasa IW, Dr. dr., SpOG-K

    Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Brawijaya, Dr. Saiful Anwar Hospital, Malang, Indonesia.

    PRINCIPAL INVESTIGATOR

  • Putu Doster Mahayasa, dr., SpOG-K

    Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Udayana, Sanglah Hospital, Denpasar, Indonesia.

    PRINCIPAL INVESTIGATOR

  • Syarief Taufik, dr., SpOG-K

    Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia.

    PRINCIPAL INVESTIGATOR

  • Nusratuddin Abdullah, Dr. dr., SpOG-K, MARS

    Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Hasanuddin, Dr. Wahidin Sudirohusodo Hospital, Makasar, Indonesia.

    PRINCIPAL INVESTIGATOR

  • Iwan Darma Putra, dr., SpOG-K

    Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Lambung Mangkurat, Ulin Banjarmasin Hospital, Banjarmasin, Indonesia.

    PRINCIPAL INVESTIGATOR

  • Eddy Suparman, Prof. Dr. dr., SpOG-K

    Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Sam Ratulangi, Prof. Dr. Kandou Hospital, Manado, 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 26, 2013

First Posted

December 3, 2013

Study Start

October 1, 2014

Primary Completion

February 1, 2019

Study Completion

May 1, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

ID(7)