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NCT01331551 · ClinicalTrials.gov registry record
Mesalamine and Reproductive Health Study
A clinical trial, sponsored by Harvard School of Public Health (HSPH).
- Completed
- Registry status
- 130
- Enrollment target
NCT01331551: Completed study, sponsored by Harvard School of Public Health (HSPH).
NCT01331551 is a clinical trial that has completed, run by Harvard School of Public Health (HSPH). The registered enrollment target is 130 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331551 has completed, sponsored by Harvard School of Public Health (HSPH).
- COMPLETED
- Registry status
- 130 participants
- Enrollment target
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2010-05 |
| Est. Completion | 2018-08 |
What the finished NCT01331551 record still lists
NCT01331551 is an observational study that tracks outcomes without assigning an intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01331551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331551 about?
NCT01331551 is a clinical study titled "Mesalamine and Reproductive Health Study". 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 hormone...
What is the current status of trial NCT01331551?
This trial is currently completed. The enrollment target is 130 participants. The study started on 2010-05. Estimated completion is 2018-08.
Who is sponsoring clinical trial NCT01331551?
This trial is sponsored by Harvard School of Public Health (HSPH), which has 40 total clinical trials registered on ClinicalTrials.gov.
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