Ignite Creation Date:
2024-05-05 @ 11:27 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01331551
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2011-04-06
Brief Title:
Mesalamine and Reproductive Health Study
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
Crossover Study on Human Exposure to Phthalates and Male Fertility
Status:
COMPLETED
Status Verified Date:
2018-07
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:
MARS
Brief Summary:
The purpose of this study is to investigate the relationship of high exposure to dibutyl phthalate DBP from the use of Asacol with clinical and intermediate markers of male fertility including semen quality sperm DNA damage transcript profiles of sperm mRNA and sncRNAs and reproductive hormones
Hypothesis 1 High exposure to DBP from the use of Asacol is associated with decreased sperm concentration and motility and increased sperm DNA damage
Hypothesis 2 High exposure to DBP from the use of Asacol is associated with decreased serum testosterone altered LHtestosterone ratio and decreased inhibin-B
Hypothesis 3 High exposure to DBP from the use of Asacol is associated with altered transcript profiles of sperm mRNAs and sncRNAs
Hypothesis 1 High exposure to DBP from the use of Asacol is associated with decreased sperm concentration and motility and increased sperm DNA damage
Hypothesis 2 High exposure to DBP from the use of Asacol is associated with decreased serum testosterone altered LHtestosterone ratio and decreased inhibin-B
Hypothesis 3 High exposure to DBP from the use of Asacol is associated with altered transcript profiles of sperm mRNAs and sncRNAs
Detailed Description:
There are 2 ways you can participate in the study
OPTION 1 involves 6 one-hour visits to the Massachusetts General Hospital MGH Andrology Clinic over a 9 month period At each visit you would be asked to fill out questionnaires and to provide a urine semen and blood sample Following Visit 2 you are asked to switch your brand of mesalamine medication After 4 months you change back to your original brand of medication The change in medication will be done in consultation with your primary GI doctor If the cost of co-payment is greater for the new brand of medication we will provide compensation to cover the difference In the case you do not have prescription drug health insurance coverage the study will reimburse up to 4000 to cover the cost for Asacol Pentasa or Lialda medication taken during your study participation
OPTION 2 involves 4 one-hour visits to MGH Andrology clinic At each visit you complete questionnaires and provide a blood urine and semen sample You are eligible for Option 2 if you are currently taking Asacol or Asacol HD and do not want to change your medication
OPTION 1 involves 6 one-hour visits to the Massachusetts General Hospital MGH Andrology Clinic over a 9 month period At each visit you would be asked to fill out questionnaires and to provide a urine semen and blood sample Following Visit 2 you are asked to switch your brand of mesalamine medication After 4 months you change back to your original brand of medication The change in medication will be done in consultation with your primary GI doctor If the cost of co-payment is greater for the new brand of medication we will provide compensation to cover the difference In the case you do not have prescription drug health insurance coverage the study will reimburse up to 4000 to cover the cost for Asacol Pentasa or Lialda medication taken during your study participation
OPTION 2 involves 4 one-hour visits to MGH Andrology clinic At each visit you complete questionnaires and provide a blood urine and semen sample You are eligible for Option 2 if you are currently taking Asacol or Asacol HD and do not want to change your medication
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