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Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619552
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Vanderbilt University
Milton S. Hershey Medical Center
Mercy Medical Center
Information provided by (Responsible Party):
Raymond Cross, University of Maryland, College Park

Brief 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.


Condition or disease Intervention/treatment
Crohn's Disease IBD Drug: Anti-TNF Drug: Steroids

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
Actual Study Start Date : August 2011
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
Anti-TNF (Remicade, Humira or Cimzia) for luminal CD
All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
Drug: Anti-TNF
All participants in this arm receive an anti-TNF for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
Other Name: Remicade, Humira, Cimzia

Anti-TNF (Remicade, Humira or Cimzia)for perianal CD
All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
Drug: Anti-TNF
All participants in this arm receive an anti-TNF for the treatment of perianal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
Other Name: Remicade, Humira, Cimzia

Steroid (Prednisone or budesonide) for luminal CD
All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
Drug: Steroids
All participants in this arm receive steroids for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
Other Name: Prednisone, Budesonide




Primary Outcome Measures :
  1. Assessment of Sexual Function [ Time Frame: 6 months ]
    Sexual Function Questionnaire

  2. Assessment of Disease Activity [ Time Frame: 6 months ]
    Harvey Bradshaw Index

  3. Assessment of Quality of Life [ Time Frame: 6 months ]
    Short Inflammatory Bowel Disease Questionnaire

  4. Assessment of Body Image [ Time Frame: 6 months ]
    Body Image Scale

  5. Assessment of Depression [ Time Frame: 6 months ]
    PHQ 9

  6. Assessment of Perianal Disease Activity [ Time Frame: 6 months ]
    Perianal Disease Activity Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators are planning a study with 60 experimental participants and 30 control participants. The investigators will recruit participants from multiple referral centers for IBD with an existing population of nearly 5,000 patients.
Criteria

Inclusion Criteria:

  • Diagnosis of Crohn's disease confirmed by standard criteria
  • Active luminal Crohn's disease defined by an HBI score of >4 or with draining perianal Crohn's disease a) Active perianal Crohn's disease defined a presence of draining perianal fistula on physical exam19
  • Patients with active luminal Crohn's disease must be initiating treatment with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi) or a steroid (prednisone, Entocort, or Uceris).
  • Patients with active perianal disease must be initiating therapy with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi).
  • Can understand written instructions in English

Exclusion Criteria:

  • Previous primary non-response to an anti-TNF
  • Uncontrolled medical or psychiatric disease (a. Degenerative neurologic condition, b.Unstable angina, c.Class III/IV congestive heart failure, d.Severe asthma or chronic obstructive pulmonary disease, e.Symptomatic peripheral vascular disease, f. Chronic renal insufficiency (creatinine > 2.0), g. Malignancy within the last 3 years (excluding squamous or basal cell cancers of the skin), h. Poorly controlled depression, mania, and schizophrenia, i. Active infection, j. Acquired immunodeficiency syndrome)
  • Inability to adhere to the protocol
  • Need for imminent surgery other than an exam under anesthesia
  • Under 18 years of age.
  • Pregnancy
  • Use of concurrent prednisone >30 mg per day in the anti-TNF groups

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619552


Locations
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United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21201
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Sponsors and Collaborators
University of Maryland, Baltimore
Vanderbilt University
Milton S. Hershey Medical Center
Mercy Medical Center
Investigators
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Principal Investigator: Raymond Cross, MD, MS University of Maryland, Baltimore

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Responsible Party: Raymond Cross, Professor of Medicine, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02619552    
Other Study ID Numbers: HP-00050472
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Prednisone
Budesonide
Adalimumab
Infliximab
Certolizumab Pegol
Phenobarbital
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Anticonvulsants