Health Assessment Study (0954-946)
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00541684
- Lead Sponsor
- Organon and Co
- Brief Summary
The study will look at the effects of losartan or atenolol on frequency of sexual intercourse in subjects with newly diagnosed mild to moderate hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 143
Inclusion Criteria
- Newly diagnosed with mild to moderate hypertension\
- Married male in stable heterosexual relationship
- No prior history of sexual dysfunction
- Satisfied with overall sex life
- Patient's spouse is in close proximity for the study
- Has had at least 2 but not more than 10 sexual intercourse events during the 2 week period prior to study start
- Patient able to visit doctor in the morning of each scheduled visit
- Able to complete the self administered health assessment questionnaire
Exclusion Criteria
- Hypertension due to cancer, history of heart or circulatory problems
- History of mental disorder that might impair sexual function
- History or presence of drug or alcohol abuse
- Prior surgery for erectile dysfunction or other urological procedure
- No penile implant or assist devices
- History of chronic liver disease, history of diabetes
- History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test
- Subjects with only 1 kidney
- Mental handicap or legal incapacity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method number of sexual intercourse events in a 2-week period 2 Weeks
- Secondary Outcome Measures
Name Time Method sexual functioning score and overall sexual satisfaction score after 16 weeks 16 Weeks