NCT00541684

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jul 2001

Typical duration for phase_3 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2001

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

October 5, 2007

Last Update Submit

August 13, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • number of sexual intercourse events in a 2-week period

    2 Weeks

Secondary Outcomes (1)

  • sexual functioning score and overall sexual satisfaction score after 16 weeks

    16 Weeks

Interventions

MK0954, /Duration of Treatment : 16 WeeksDRUG
Comparator : atenolol /Duration of Treatment : 16 WeeksDRUG

Eligibility Criteria

Age40 Years - 49 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Duration of Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 10, 2007

Study Start

July 11, 2001

Primary Completion

January 23, 2003

Study Completion

January 23, 2003

Last Updated

August 15, 2024

Record last verified: 2022-02