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NCT02619552 · ClinicalTrials.gov registry record
Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
A clinical trial, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- 50
- Enrollment target
NCT02619552: Completed study, sponsored by University of Maryland, Baltimore.
NCT02619552 is a clinical trial that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02619552 has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects. Previous studies have shown that sexual function is impaired in patients with Crohn's disease. It is likely that both the symptoms related to the disease, medications used to treat the disease, and surgery all impair sexual function in a variety of ways. For example, body image may be impaired, patients may be worried about bowel incontinence or unpleasant odors associated with diarrhea, patients may have significant pelvic pain secondary to perianal fistulas, or they may have painful intercourse from adjacent inflammation or scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual function is not known. The investigators propose a 6 month study to compare sexual function before and after treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with steroids. The investigators anticipate that the investigators will show that therapy with an anti TNF agent will result in a more rapid and greater return of sexual function than steroids. This information will be important to help counsel patients about the optimal treatment to begin for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate the impact of medical therapy on sexual function.
Primary Outcome
Sexual Function Questionnaire
Interventions
- DRUG Steroids
- DRUG Anti-TNF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-08 |
| Est. Completion | 2019-07-01 |
What the finished NCT02619552 record still lists
NCT02619552 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Steroids is the first listed.
NCT02619552 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02619552 about?
NCT02619552 is a clinical study titled "Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease". Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects. Previous studies hav...
What is the current status of trial NCT02619552?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2011-08. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT02619552?
The interventions under investigation include: Steroids (DRUG), Anti-TNF (DRUG).
Who is sponsoring clinical trial NCT02619552?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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