Phase
Condition
Hormone Deficiencies
Diabetes (Pediatric)
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages 18-40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 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).
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.
Exclusion
Exclusion Criteria:
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.
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
- Participating in other clinical trial within 30 days prior to screening.
Study Design
Study Description
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,
IndonesiaSite Not Available
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Udayana, Sanglah Hospital
Denpasar,
IndonesiaSite Not Available
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Hasanuddin, Dr. Wahidin Sudirohusodo Hospital
Makasar,
IndonesiaSite Not Available
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Brawijaya, Dr. Saiful Anwar Hospital
Malang,
IndonesiaSite 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,
IndonesiaSite Not Available
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital
Semarang,
IndonesiaSite Not Available
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Airlangga, Dr. Soetomo Hospital.
Surabaya,
IndonesiaSite Not Available
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