Trials / Terminated
TerminatedNCT00529230
Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 46 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: 1\. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes. Secondary Objective: 1\. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Questionnaire | 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. |
Timeline
- Start date
- 2001-12-11
- Primary completion
- 2004-02-19
- Completion
- 2004-02-19
- First posted
- 2007-09-14
- Last updated
- 2018-10-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00529230. Inclusion in this directory is not an endorsement.