NCT00324948

Brief Summary

Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

2 active sites

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

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 10, 2009

Status Verified

March 1, 2009

Enrollment Period

1.9 years

First QC Date

May 9, 2006

Last Update Submit

March 9, 2009

Conditions

Sexual Dysfunction, Physiological

Keywords

Female sexual arousal disorderFemale sexual dysfunction

Outcome Measures

Primary Outcomes (1)

  • FSEP

Secondary Outcomes (3)

  • FSFI

  • Global assessment

  • Adverse events

Interventions

Topical alprostadil (PGE-1)DRUG

Eligibility Criteria

Age21 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 21-60 who have undergone a hysterectomy
  • Have a primary diagnosis of female sexual arousal disorder
  • Be willing to comply with all study requirements and visit schedules

You may not qualify if:

  • Known allergy to alprostadil or product excipients
  • Have a genital inflammatory or infectious condition or STD
  • Have a significant medical condition that would interfere with the study
  • Have received an investigational drug within the prior 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine-Dept of OB/GYN

Stanford, California, 94305, United States

Location

Radiant Research

Cincinnati, Ohio, 95249, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Sam Teichman, MD

    Vivus Clinical Research Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

September 1, 2004

Primary Completion

August 1, 2006

Study Completion

November 1, 2006

Last Updated

March 10, 2009

Record last verified: 2009-03

Locations

US(2)