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| Sponsored by: |
VIVUS, Inc. |
|---|---|
| Information provided by: | VIVUS, Inc. |
| ClinicalTrials.gov Identifier: | NCT00324948 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Sexual Dysfunction, Physiological |
Drug: Topical alprostadil (PGE-1) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical Alprostadil in Hysterectomized Women With Female Sexual Arousal Disorder (FSAD) |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2004 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study involving about 300 women who are 21-60 years of age inclusive, who have undergone a hysterectomy (with or without oophorectomy), and who have a primary diagnosis of FSAD. The diagnosis of FSAD will be made based on a medical and sexual history and confirmed using a structured interview by trained personnel. Study subjects will undergo a 2-month non-treatment run-in period followed by a 6-month period of blinded study therapy. Study drug is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity. Study subjects will complete several questionnaires at various times during the study and will complete a daily diary.
The study endpoint is based on the FSEP and other standard questionnaires, as well as safety and tolerability of study drug.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University School of Medicine-Dept of OB/GYN | |
| Stanford, California, United States, 94305 | |
| United States, Ohio | |
| Radiant Research | |
| Cincinnati, Ohio, United States, 95249 | |
| Study Director: | Sam Teichman, MD | Vivus Clinical Research Department |
More Information
| Responsible Party: | Vivus, Inc. ( Wesley Day, VP Clinical ) |
| Study ID Numbers: | Vivus-FSD-10 |
| Study First Received: | May 9, 2006 |
| Last Updated: | March 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00324948 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Female sexual arousal disorder Female sexual dysfunction |
|
Alprostadil Genital Diseases, Female Sexual Dysfunctions, Psychological Vasodilator Agents Fibrin Modulating Agents Sexual Dysfunction, Physiological |
Mental Disorders Platelet Aggregation Inhibitors Fibrinolytic Agents Cardiovascular Agents Genital Diseases, Male |
|
Sexual Dysfunctions, Psychological Alprostadil Vasodilator Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Genital Diseases, Male |
Sexual and Gender Disorders Pharmacologic Actions Genital Diseases, Female Fibrin Modulating Agents Sexual Dysfunction, Physiological Mental Disorders Therapeutic Uses Platelet Aggregation Inhibitors |
