Mesalamine and Reproductive Health Study

Crohn Disease Clinical Trial

— MARS  

Official title:

Crossover Study on Human Exposure to Phthalates and Male Fertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331551
• Other study ID #: 5R01ES17285-2
• Status: Completed
• Start date: May 2010
• Est. completion date: August 2018

Study information

• Verified date: July 2018
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis Ulcerative
• Colitis, Ulcerative
• Crohn Disease

Locations

Country	Name	City	State
United States	Massachuetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health	Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.