Mesalamine and Reproductive Health Study

Completed

Conditions studied: Colitis Ulcerative, Crohn Disease

In brief

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.

Key facts

Study ID

NCT01331551

Run by

Harvard School of Public Health (HSPH)

People needed

130

Starts

2010-05-01

Expected to finish

2018-08-01

Last updated by the study team

2018-08-02

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachuetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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