Age
18 - 40
Check your eligibility now & get in touch with a study center
CHECK ELIGIBILITYWhat is Polycystic Ovary Syndrome?
Polycystic ovary syndrome, or PCOS, is a hormonal condition that women can get during their childbearing years. It can affect their ability to have a child (called fertility). It can also:
- Stop periods or make them hard to predict
- Cause acne and unwanted body and facial hair
- Raise risk of other health problems, including diabetes and high blood pressure
Women can get treatments for the symptoms and be able to get pregnant, although they may need to take medicines to improve fertility. Some women with PCOS have cysts on their ovaries. That’s why it’s called “polycystic.” But the name is misleading because many women with PCOS don’t have cysts.
What Do Hormones Have to Do With PCOS?
Women with PCOS have reproductive hormones out of balance. This can lead to problems with ovaries, such as not having periods on time or not getting it. Women body makes hormones to make different things happen. Some affect menstrual cycle and are tied to the ability to have a baby. The hormones that play a role in PCOS include:
- Androgens: They’re often called male hormones, but women have them, too. Women with PCOS tend to have higher levels.
- Insulin: This hormone manages blood sugar. With PCOS, the body might not react to insulin the way it should.
- Progesterone: With PCOS, body may not have enough of this hormone. This might lead to missing periods for a long time or have trouble predicting when they’ll come.
What Are the Symptoms of PCOS?
The most common PCOS symptoms are missed, irregular, infrequent, or prolonged periods. Excess androgens can cause hair loss, hair in places you don’t want it (like on your face), and acne. Other symptoms include:
- Darkened skin or excess skin (skin tags) on the neck or in the armpits
- Mood changes
- Pelvic pain
- Weight gain around your middle
What Are the Causes of PCOS?
Doctors don’t know all of the reasons why some women get PCOS. You might be more likely to have PCOS if your sister or mother also has it. It could also be related to problems that make your body produce too much insulin, which can affect your ovaries and their ability to ovulate (or release eggs).
What Complications Can PCOS Be Linked With?
If you have PCOS and your androgen levels are too high, you have higher odds for a number of complications. These can differ from woman to woman and include:
- Trouble getting pregnant: Cysts in the ovaries can interfere with ovulation. That’s when one of your ovaries releases an egg each month. If a healthy egg isn’t available to be fertilized by a sperm, you can’t get pregnant. You may still be able to get pregnant if you have PCOS. But you might have to take medicine and work with a fertility specialist to make it happen.
- Insulin issues and diabetes: Insulin resistance may cause your body to make too many androgens. If you have insulin resistance, the cells in your muscles, organs, and other tissues don’t absorb blood sugar very well. As a result, you can have too much sugar moving through your bloodstream. This is called diabetes, and it can cause problems with your cardiovascular and nervous systems.
- Metabolic syndrome: This group of symptoms raises the risk of cardiovascular disease. The symptoms include high triglyceride and low HDL (“good”) cholesterol levels, high blood pressure, and high blood sugar levels.
Other common complications of PCOS include:
- Depression.
- Anxiety.
- Bleeding from the uterus and higher risk of uterine cancer.
- Sleep problems.
- Inflammation of the liver.
About The Trial:
The trial is about PCOS Treatment Using DLBS3233, Metformin, and Combination of Both (POSITIF).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.
Detailed 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.
Arms And Interventions
Arm | Intervention/treatment |
Experimental:
Treatment I : DLBS3233 DLBS3233
100 mg capsule once daily, and Placebo metformin caplet twice daily; orally,
for 6 months | Drug:
DLBS3233 Other
Name: Inlacin
Placebo
metformin has the same ingredients with Metformin XR caplet, except that it
does not contain the active substance (metformin). |
Active
Comparator: Treatment II : Metformin Metformin
XR 750 mg caplet twice daily, and Placebo DLBS3233 once daily; orally, for 6
months | Drug:
Metformin XR Other
Name: Glumin XR
Placebo
DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does
not contain the active substance (DLBS3233). |
Experimental:
Treatment III : Combination DLBS3233 and Metformin DLBS3233
100 mg capsule once daily, and Metformin XR 750 mg caplet twice daily;
orally, for 6 months. | Drug:
DLBS3233 Other
Name: Inlacin
Other
Name: Glumin XR |
Eligibility Criteria
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 gynaecological 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.
Gender
Female
NCT ID
NCT01999686
Phase
-1
Status
Recruiting Now
Medical Condition
Polycystic Ovary Syndrome
Your Journey
01
Receiving the medication
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
02
Visiting the study site
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.
03
Follow-up
No visits are required after participation is complete.
Contact Form
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