PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

Last updated: May 24, 2019
Sponsor: Dexa Medica Group
Overall Status: Completed

Phase

3

Condition

Hormone Deficiencies

Diabetes (Pediatric)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT01999686
DLBS3233-1013
  • Ages 18-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed written informed consent prior to participation in the study.

  2. Female subjects in reproductive age (i.e. 18-40 years) willing to conceive.

  3. Subject with a diagnosis of polycystic ovary syndrome confirmed by two of thefollowing (Rotterdam Criteria):

  • Hyperandrogenism (defined by elevated free testosterone concentration; orFerriman-Gallwey Score of ≥ 8).

  • Ovarian dysfunction indicated by menstrual irregularity: oligomenorrhea (cyclesof > 35 days), or amenorrhea (no menses in the last of 3 months) after negativescreening pregnancy test.

  • Polycystic ovary as shown by ultrasonography (USG).

  1. Subject with insulin resistance defined by : HOMA-IR of > 2.00.

  2. Subject with body mass index (BMI) of 19-35 inclusive.

  3. Able to take oral medication.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women (urinary pregnancy test will be applied at screening).

  2. 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.
  1. Known to have the following medical condition:

  • Diabetes mellitus,

  • Uncontrolled hypertension

  • Symptomatic cardiovascular diseases:

  • Acute or chronic infections at baseline.

  • Any known malignancies.

  1. History of gynecological surgery.

  2. Impaired renal function

  3. Impaired liver function

  4. Medically-assisted weight loss with medications or surgical procedures.

  5. Currently having laparoscopic ovarian diathermy (LOD).

  6. Currently under treatment with in vitro fertilization (IVF) techniques.

  7. Have been regularly taking any of the following medications, within ≤ 3 months priorto screening, such as:

  • Clomiphene citrate

  • Insulin sensitizers, i.e. metformin and thiazolidinediones

  • Aromatase inhibitors, such as: anastrozole, letrozole

  • Glucocorticoids

  • Gonadotropins

  • Gonadotropin-releasing hormone agonists (GnRHa)

  • Oral contraceptive pills (OCPs)

  • Antiandrogens, such as: spironolactone, cyproterone acetate (CPA), and flutamide

  • Any traditional or herbal medicines

  1. Participating in other clinical trial within 30 days prior to screening.

Study Design

Total Participants: 186
Study Start date:
October 01, 2014
Estimated Completion Date:
May 31, 2019

Study Description

There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following:

  • Treatment I : DLBS3233 100 mg once daily

  • Treatment II : Metformin XR 750 mg twice daily

  • Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily.

Laboratory examination to evaluate metabolic efficacy parameters will be performed at baseline, Month 3rd, and end of study (Month 6th).

Clinical and laboratory examination to evaluate the reproductive efficacy parameters using trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at baseline to the end of study.

Safety examination will be performed at baseline and end of study. Occurrence of adverse event will be observed along the study conduct.

Connect with a study center

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

    Banjarmasin,
    Indonesia

    Site Not Available

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

    Denpasar,
    Indonesia

    Site Not Available

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

    Makasar,
    Indonesia

    Site Not Available

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

    Malang,
    Indonesia

    Site Not Available

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

    Manado,
    Indonesia

    Site Not Available

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

    Semarang,
    Indonesia

    Site Not Available

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

    Surabaya,
    Indonesia

    Site Not Available

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