NCT00353171

Brief Summary

This study will examine whether exposure to organochlorines (certain chemicals such as PCBs and DDE, used in pesticides or other industrial applications) is related to age at natural menopause. It is known, for example, that smokers experience menopause 1 to 2 years earlier than do non-smokers. This study will look for a similar association between organochlorine exposure and menopause. It will also look for possible associations between specific factors, such as pregnancy history and weight change, and changes over time in blood organochlorine levels. Women who participated in the North Carolina Infant Feeding Study between 1978 and 1982 are eligible for this study. Participants will be interviewed over the phone for information about their reproductive and menstrual history, as well as additional information that may be related to age and menopausal status. Specifically, the interview will cover the following areas: 1) pregnancy and breastfeeding history; 2) menstrual periods and menopause; 3) use of birth control pills and hormone replacement therapy; 4) surgeries on the uterus or ovaries, such as hysterectomy or oophorectomy, or both; 5) smoking and alcoholic beverage consumption; 6) physical activity; 7) weight history; and 8) medical history. About one-half of the participants will have a blood sample drawn for analysis of the reproductive hormones FSH (follicle-stimulating hormone) and LH (leuteinizing hormone) and of DDE and PCB levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
514

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2003

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
12.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
Last Updated

June 17, 2019

Status Verified

May 29, 2019

First QC Date

July 17, 2006

Last Update Submit

June 14, 2019

Conditions

Keywords

SmokingPCBDDEMenstrual CycleNC Infant Feeding Study

Outcome Measures

Primary Outcomes (1)

  • Organochlorine & Nat. Menopause

Secondary Outcomes (1)

  • Rate of change of organochlorine levels

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • There are 8 women in the cohort whose study children are known to have died. We will exclude these women from this follow-up study.
  • This leaves 857 women that are eligible for tracing the follow-up interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (3)

  • McKinlay SM, Bifano NL, McKinlay JB. Smoking and age at menopause in women. Ann Intern Med. 1985 Sep;103(3):350-6. doi: 10.7326/0003-4819-103-3-350.

    PMID: 4026083BACKGROUND
  • Cramer DW, Xu H. Predicting age at menopause. Maturitas. 1996 Apr;23(3):319-26. doi: 10.1016/0378-5122(96)00992-9.

    PMID: 8794427BACKGROUND
  • Luoto R, Kaprio J, Uutela A. Age at natural menopause and sociodemographic status in Finland. Am J Epidemiol. 1994 Jan 1;139(1):64-76. doi: 10.1093/oxfordjournals.aje.a116936.

    PMID: 8296776BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Donna D Baird, Ph.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

March 1, 2003

Study Completion

May 29, 2019

Last Updated

June 17, 2019

Record last verified: 2019-05-29

Locations