NCT00455338

Brief Summary

The primary objective is to determine if meals of different fat and fiber content affect postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our hypothesis is that a high-fiber meal will have a greater reduction in testosterone composition compared with a high-fat meal.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2005

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
Last Updated

April 3, 2007

Status Verified

April 1, 2007

First QC Date

April 2, 2007

Last Update Submit

April 2, 2007

Conditions

Polycystic Ovary Syndrome

Keywords

mealcompositionpostprandialPCOSandrogen

Outcome Measures

Primary Outcomes (1)

  • Testosterone

Secondary Outcomes (3)

  • SHBG

  • Glucose

  • Insulin

Interventions

Meal CompositionBEHAVIORAL

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic oligo/anovulation - intermenstrual periods of ≥ 45 days or ≤ 8 menses per year.
  • Hyperandrogenemia - elevated total testosterone or free androgen index (ratio of testosterone/SHBG x 100). To participate in the study, women must have total testosterone \>50 ng/dL or a free androgen index \>1.5
  • In good general health

You may not qualify if:

  • Currently pregnant or lactating
  • Use of confounding medications such as oral contraceptives or other hormonal medication, lipid lowering medications or insulin sensitizing agents such as metformin or the glitazones.
  • Tobacco use
  • Alcohol consumption of more than two drinks per day
  • Unusual meal patterns (including no breakfast, breakfast before 6 am or breakfast after 10am.
  • Untreated hyperprolactinaemia (Prolactin \>25ng/ml)
  • Uncontrolled hypothyroidism
  • History of blood clotting disorder
  • Diagnosis of anemia at baseline visit
  • Presence or history of diabetes mellitus
  • Existence of an organic intra cranial lesion such as a pituitary tumor.
  • Presence or history of coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Richard S Legro, M.D.

    Department of Obstetrics and Gynecology; Pennsylvania State University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 3, 2007

Study Start

May 1, 2005

Study Completion

November 1, 2006

Last Updated

April 3, 2007

Record last verified: 2007-04