NCT00497653

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

6.4 years

First QC Date

July 5, 2007

Last Update Submit

November 15, 2011

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood.

    43 days

Study Arms (2)

DCI

EXPERIMENTAL
Drug: DCI

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DCIDRUG

D-chiro-inositol 1200mg twicely daily for 6 weeks

DCI
PlaceboDRUG

Placebo, twice daily for 6 weeks

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • John E. Nestler, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 9, 2007

Study Start

February 1, 2001

Primary Completion

July 1, 2007

Study Completion

July 1, 2009

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

US(1)