NCT00011388

Brief Summary

This project is examining the reproductive effects of exposure to certain compounds that are suspected to act on the endocrine system, e.g. they may act like or interfere with hormones such as estrogen. The study is being conducted among Laotian women, as it is suspected that they may have higher exposures to the compounds of interest (pesticides and PCBs) from their homeland and from consumption of fish caught in the San Francisco Bay. Fifty Laotian immigrants were recruited by community workers to collect urine daily during 3 menstrual cycles for measurement of steroid hormones (estrogen and progesterone). Additionally, they provided a blood sample to measure exposure levels, and completed 2 interviews in their native language. These measured levels, as well as the self-reported data on a number of factors including fish consumption, will be examined for possible effects on hormone levels and menstrual function.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

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

First Submitted

Initial submission to the registry

February 16, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2001

Completed
Last Updated

March 23, 2006

Status Verified

March 1, 2006

First QC Date

February 16, 2001

Last Update Submit

March 22, 2006

Conditions

AmenorrheaDysmenorrheaOligomenorrheaAnovulationInfertility

Keywords

Organochlorine compoundsEndocrine disruptorsSex HormonesReproductive functionMenstrual Disturbances

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Eligibility requirements based on need to measure reproductive hormones and menstrual function in relation to hypothesized exposure. So women had to be born in SE Asia, consume fish regularly, have a menstrual period in last 6 weeks, and not be taking any hormone medications.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

AmenorrheaDysmenorrheaOligomenorrheaAnovulationInfertility

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

February 16, 2001

First Posted

February 19, 2001

Last Updated

March 23, 2006

Record last verified: 2006-03