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NCT00472940 Clinical Trial

Prevalence of Hypogonadism in Male Cancer Patients

Cancer Clinical Trial

Official title:
Prevalence of Hypogonadism in Male Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00472940
Other study ID # H-19709
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2006
Est. completion date September 2, 2020

Study information
Verified date November 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cancer and its complications are common problems. In most cases, this condition has a profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased sexual drive, depression and poor appetite are commonly seen in these patients. However, these symptoms also are seen in men with other conditions including those with low testosterone levels. The objective of this study is to determine the number of male patients with cancer that have low testosterone levels and to establish the relationship between testosterone levels and the symptoms that these patients experience.

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date September 2, 2020
Est. primary completion date September 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male subjects = 18 years of age with histological diagnosis of cancer for cancer group. 2. Provide written informed consent prior to screening. 3. Histological diagnosis of cancer other than non-melanoma skin cancer for the two cancer groups. Exclusion Criteria: 1. Concomitant use of GH, Megestrol, Marinol, or any other anabolic agent, appetite stimulant (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feedings, or parenteral nutrition during the 3 months prior to entering the study. 2. Participation in a clinical trial with investigational agents within 1 month of enrollment. 3. Prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Michael E. DeBakey Veterans Affairs Medical Center Houston Texas

Sponsors (3)
Lead Sponsor Collaborator
Baylor College of Medicine Michael Debakey Veterans Affairs Medical Center, Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Garcia JM, Li H, Mann D, Epner D, Hayes TG, Marcelli M, Cunningham GR. Hypogonadism in male patients with cancer. Cancer. 2006 Jun 15;106(12):2583-91. — View Citation

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