PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome (PCOS) Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment I : DLBS3233

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

Group Type EXPERIMENTAL

DLBS3233

Intervention Type DRUG

Placebo metformin

Intervention Type DRUG

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

Treatment II : Metformin

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

Group Type ACTIVE_COMPARATOR

Metformin XR

Intervention Type DRUG

Placebo DLBS3233

Intervention Type DRUG

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

Treatment III : Combination DLBS3233 and Metformin

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

Group Type EXPERIMENTAL

DLBS3233

Intervention Type DRUG

Metformin XR

Intervention Type DRUG

Interventions

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DLBS3233

Intervention Type DRUG

Metformin XR

Intervention Type DRUG

Placebo metformin

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

Intervention Type DRUG

Placebo DLBS3233

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

Intervention Type DRUG

Other Intervention Names

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Inlacin Glumin XR

Eligibility Criteria

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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 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).
4. Subject with insulin resistance defined by : HOMA-IR of \> 2.00.
5. Subject with body mass index (BMI) of 19-35 inclusive.
6. Able to take oral medication.

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.
3. Known to have the following medical condition:

* Diabetes mellitus,
* Uncontrolled hypertension
* Symptomatic cardiovascular diseases:
* Acute or chronic infections at baseline.
* Any known malignancies.
4. History of gynecological surgery.
5. Impaired renal function
6. Impaired liver function
7. Medically-assisted weight loss with medications or surgical procedures.
8. Currently having laparoscopic ovarian diathermy (LOD).
9. Currently under treatment with in vitro fertilization (IVF) techniques.
10. Have been regularly taking any of the following medications, within ≤ 3 months prior to 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
11. Participating in other clinical trial within 30 days prior to screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soehartono Ds, Prof. dr., SpOG-K

Role: PRINCIPAL_INVESTIGATOR

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

Arsana Wiyasa IW, Dr. dr., SpOG-K

Role: PRINCIPAL_INVESTIGATOR

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

Putu Doster Mahayasa, dr., SpOG-K

Role: PRINCIPAL_INVESTIGATOR

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

Syarief Taufik, dr., SpOG-K

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

Iwan Darma Putra, dr., SpOG-K

Role: PRINCIPAL_INVESTIGATOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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