Organochlorine Exposure in Relation to Timing of Natural Menopause
2 other identifiers
observational
514
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2003
Longer than P75 for all trials
1 active site
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
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 17, 2006
CompletedFirst Posted
Study publicly available on registry
July 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2019
CompletedJune 17, 2019
May 29, 2019
July 17, 2006
June 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Organochlorine & Nat. Menopause
Secondary Outcomes (1)
Rate of change of organochlorine levels
Eligibility Criteria
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
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: 4026083BACKGROUNDCramer DW, Xu H. Predicting age at menopause. Maturitas. 1996 Apr;23(3):319-26. doi: 10.1016/0378-5122(96)00992-9.
PMID: 8794427BACKGROUNDLuoto 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donna D Baird, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
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