Mesalamine and Reproductive Health Study
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/4/2018 |
| Start Date: | May 2010 |
| End Date: | August 2018 |
Crossover Study on Human Exposure to Phthalates and Male Fertility
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 LH:testosterone 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.
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 LH:testosterone 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.
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.
Inclusion Criteria:
- Must be taking mesalamine medication. Willing to switch brand of medication for 4
months or currently taking Asacol or Asacol HD.
- Has not taken steroid medication within the previous 3 months. Is able to come to MGH
hospital for 6 visits.
Exclusion Criteria:
- Is not taking mesalamine medication. Unwilling to switch brand of medication for 4
months.
- Is or has taken steroid medication within the past 3 months. Is unable to come to MGH
hospital for 6 visits.
- Has had a vasectomy or has documented infertility.
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