Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes
|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: NCT00529230|
Recruitment Status : Terminated (Low accrual rate.)
First Posted : September 14, 2007
Last Update Posted : August 1, 2012
1. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes.
1. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.
|Condition or disease||Intervention/treatment|
|Advanced Cancer Hypogonadism Pain||Behavioral: Questionnaire Other: Blood draws to assess gonadal function|
Studies have shown that non-cancer patients taking opioid pain medication for a long period of time can have decreased libido and decreased sexual function.
Individuals may be asked to take part in this study even if they have not taken opioid pain medications in the last twelve months. These individuals would also be enrolled to learn if long-term treatment of cancer-related pain with opioid medications results in decreased sex hormones, decreased sex drive, and increased fatigue or depression.
Participants in this study will be asked to complete a set of questions about their sexual functions, physical symptoms, and psychological symptoms such as fatigue and depression. It will take about 25 minutes to complete the questionnaires.
Participants will have blood drawn (about 2 teaspoons of blood) to test their sex hormone level. Participants who are identified as having low sex hormone level (hypogonadism) will be referred to an endocrinologist for standard hormone replacement therapy.
This is a one-time evaluation, no follow-up visit or questionnaires are required.
This is an investigational study. A total of 108 individuals will take part in this study. All will be enrolled at UTMDACC.
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Observational Model:||Case Control|
|Official Title:||Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes|
|Study Start Date :||December 2001|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
Chronic opioid therapy + Gonadal function
Males on chronic opioid therapy for cancer-related pain syndromes
A set of questionnaires regarding sexual function, physical and psychological symptoms.
Other: Blood draws to assess gonadal function
Testosterone, FSH, and LH levels at study onset.
- Prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes [ Time Frame: 3 Years ]
Biospecimen Retention: Samples Without DNA
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): NCT00529230
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Arun Rajagopal, MD||M.D. Anderson Cancer Center|