Mesalamine and Reproductive Health Study

NCT01331551 | Completed

• 2 other identifiers: 5R01ES17285-25R01ES017285
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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 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

Keywords

Inflammatory Bowel disease

Outcome Measures

Primary Outcomes (1)

• Altered semen quality and sperm transcriptome analysis

  Initial analysis takes place approximately 4-5 months after patient enrolls and after he has completed first crossover of medication. The second phase takes place about 8-10 months later after he crosses back to original medication.

Secondary Outcomes (1)

• Serum levels of reproductive hormones

  Analysis of hormone levels take place at the same intervals described above, 4-5 months after enrollment and then again 8-10 months after enrollment when patient has resumed taking orginal medication.

Study Arms (1)

men with inflammatory bowel disease

Men between the ages of 18-55 with inflammatory bowel disease who are taking mesalamine medication.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men between the ages of 18-55 who have inflammatory bowel disease.

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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Boston Children's Hospital: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachuetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for hormones, urine for phthalates, semen for DNA and RNA

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Russ B Hauser, MD, ScD, MPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 8, 2011
• Study Start: May 1, 2010
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)