Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353171
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2006-07-17
Brief Title:
Organochlorine Exposure in Relation to Timing of Natural Menopause
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Organochlorine Exposure in Relation to Timing of Natural Menopause
Status:
COMPLETED
Status Verified Date:
2019-05-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Smoking has been shown in many studies to be associated with a 1-2 year decrease in age at natural menopause However relatively little is known about the effect of other potential toxicants including organochlorines such as polychlorinated biphenyls PCBs and 1 1 dichloro-22-bisp-chlorophenyl ethylene pp -DDE referred to subsequently as DDE We will assess timing of menopause among women who participated in the North Carolina Infant Feeding Study total n 865 Recruitment for this study was conducted between 1978 and 1982 PCB and DDE levels were analyzed in blood and breast milk samples around delivery and after pregnancy The median age of the women as of March 2002 is 50 years Data will be collected in a telephone interview focusing on reproductive and menstrual history with additional information collected on demographic social and behavioral factors that could affect timing of menopause A blood sample will be collected from approximately 50 of participants based on sampling strata that involve criteria relating to age and menopausal status Follicle stimulating hormone and luteinizing hormone will be measured in these samples in order to classify menopausal status of women who had undergone hysterectomy with retention of at least one ovary women who are currently using hormone replacement therapy whose use began while still having periods and women who report very short very long or irregular menstrual cycle lengths during the past 12 months PCB and DDE levels will also be determined in these samples allowing us to assess the correlation between current and baseline 1978-1982 PCB and DDE measures The purpose of this study is to assess the association between the baseline organochlorine measurements and timing of natural menopause A secondary aim will be to conduct exploratory analyses of the association between specific factors eg pregnancy history weight change and rate of change in organochlorine levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-E-N045 | None | None | None |