A Phase 2/3 interventional study of DCI and Placebo in Polycystic Ovary Syndrome, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2011-11-16.
Sponsored by Virginia Commonwealth University · Phase 2/3, Interventional, and Basic science
To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood, and, if so, if that change is accompanied by i) an increase in DCI-IPG release in blood (as determined by bioactivity) during an oral glucose challenge and ii) an increase in whole-body insulin sensitivity.
A total of 46 women will be studied. We will study 23 obese and 23 non-obese women. There will be no BMI restriction. Twenty-three women will be randomly assigned to receive DCI (experimental group) and 23 women to receive placebo (control group). The women will be studied during the equivalent of the follicular phase of the cycle, as documented by a serum progesterone concentration of 2 ng/ml.
PCOS will be defined using criteria developed at the 1990 NICHD conference on PCOS3 - i.e., all women will have oligomenorrhea (eight or fewer menstrual periods annually) and hyperandrogenemia (elevated serum total or free testosterone concentration), and secondary causes of hyperandrogenism or ovulatory dysfunction will be excluded (see below: Entrance Criteria). All women will undergo a standard oral glucose tolerance test (OGTT) to screen for diabetes mellitus,16 but impaired glucose tolerance (IGT) will not be an exclusion criteria because of the high prevalence of IGT in this population.8,17-19 We intentionally will not screen the women for the presence of insulin resistance. Women with PCOS who have disorders associated with insulin resistance - such as hypertension21-23 or dyslipidemia21-23 - will not be excluded as long as they have been on a stable dose of medication for 6 months.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 13 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Inclusion Criteria:-
(1) Non-obese and obese women with PCOS between 18-40 years of age. (2) oligomenorrhea ( 8 menstrual periods annually), (3) biochemical hyperandrogenemia (elevated total or free testosterone), (4) normal thyroid function tests and serum prolactin, and (5) exclusion of 21 -hydroxylase deficiency by a fasting 17 -hydroxyprogesterone \<200 ng/dl.41 (6) acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis). (7) Signed, witnessed informed consent. (8) Ability to comply with study requirements.
Exclusion Criteria: - (1) Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). (2) Current use of oral contraceptives, DepoProvera or Norplant.. (3) Documented or suspected recent (within one year) history of drug abuse or alcoholism. (4) Ingestion of any investigational drug within two months prior to study onset.
Drug: DCI
Drug: Placebo
D-chiro-inositol 1200mg twicely daily for 6 weeks
Placebo, twice daily for 6 weeks
To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood.
Time frame: 43 days
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University