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Mesalamine and Reproductive Health Study

NCT01331551 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2018-08-02

No results posted yet for this study

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 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.

Conditions

  • Colitis Ulcerative
  • Crohn Disease

Sponsors & Collaborators

Principal Investigators

  • Russ B Hauser, MD, ScD, MPH · Harvard School of Public Health (HSPH)

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331551 on ClinicalTrials.gov