Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042536
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-07-31
Brief Title:
Effects of Yohimbine and Naltrexone on Sexual Function
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Alpha-2 Adrenergic and Opiate Receptor Blockade on Sexual Function in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2004-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the drugs yohimbine and naltrexone in treating men with erectile dysfunction ED the inability to achieve or maintain penile erection for satisfactory sexual performance
ED is a medical and psychological problem that is usually associated with increased age Evidence suggests that specific neurotransmitter systems are involved in the regulation of sexual function Yohimbine and naltrexone are drugs that may influence these neurotransmitter systems This study will use different doses of yohimbine and fixed doses of naltrexone to determine their effectiveness in treating ED
Participants in this study will be screened with a medical history physical examination blood and urine tests and an electrocardiogram ECG The study will consist of three outpatient visists
ED is a medical and psychological problem that is usually associated with increased age Evidence suggests that specific neurotransmitter systems are involved in the regulation of sexual function Yohimbine and naltrexone are drugs that may influence these neurotransmitter systems This study will use different doses of yohimbine and fixed doses of naltrexone to determine their effectiveness in treating ED
Participants in this study will be screened with a medical history physical examination blood and urine tests and an electrocardiogram ECG The study will consist of three outpatient visists
Detailed Description:
Erectile dysfunction ED is a relevant medical and psychological problem for males and is usually associated with increased age There is substantial evidence available suggesting that noadrenergic and opiate transmitter systems are involved in regulation of sexual function The objective of the present study is to evaluate the effects and safety of a potential novel treatment combination for ED consisting of both the alpha-adrenoreceptor antagonist yohimbine and the opiate antagonist naltrexone The study uses a three-phase double-blind placebo-controlled cross-over design Healthy male volunteers will participate The effects of differing dosages of yohimbine 10 mg versus 20 mg and a fixed dose of naltrexone 50 mg on penile tumescene and rigidity and sexual arousal are assessed in a placebo-controlled design The anticipated risks of the study are considered minimal in relation to the importance of our increased knowledge about regulation of physiological and psychological aspects of regulation of sexual function and dysfunction This novel treatment combination could be later also applied to patients with ED of different origin eg organic psychogenic and mixed causes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-M-0262 | None | None | None |