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Oral Administration of DCI to Women With PCOS

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00497653
First received: July 5, 2007
Last updated: November 15, 2011
Last verified: November 2011

July 5, 2007
November 15, 2011
February 2001
July 2007   (final data collection date for primary outcome measure)
To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood. [ Time Frame: 43 days ] [ Designated as safety issue: No ]
To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood. [ Time Frame: 43 days ]
Complete list of historical versions of study NCT00497653 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Oral Administration of DCI to Women With PCOS
Determination if Oral DCI Administration to Women With PCOS Increases Total DCI Content in Urine and Blood...

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Polycystic Ovary Syndrome
  • Drug: DCI
    D-chiro-inositol 1200mg twicely daily for 6 weeks
  • Drug: Placebo
    Placebo, twice daily for 6 weeks
  • Experimental: DCI
    Intervention: Drug: DCI
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
July 2009
July 2007   (final data collection date for primary outcome measure)

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.

Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00497653
2R01HD35629 P2
Yes
Virginia Commonwealth University
Virginia Commonwealth University
National Institutes of Health (NIH)
Principal Investigator: John E. Nestler, MD Virginia Commonwealth University
Virginia Commonwealth University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP