Sexual Dysfunction, Physiological Clinical Trial
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)
Verified date | March 2009 |
Source | VIVUS, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 300 |
Est. completion date | November 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Radiant Research | Cincinnati | Ohio |
United States | Stanford University School of Medicine-Dept of OB/GYN | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
VIVUS, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FSEP | |||
Secondary | FSFI | |||
Secondary | Global assessment | |||
Secondary | Adverse events |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01021670 -
An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride
|
Phase 4 | |
Recruiting |
NCT02624648 -
Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women
|
Phase 1 | |
Completed |
NCT05692960 -
Women's Interventions for Sexual Health: WISH
|
N/A | |
Completed |
NCT01188720 -
Sexual Health on Antidepressants Through Physical Exercise
|
N/A | |
Completed |
NCT00692419 -
Pain, Sexual Dysfunction, and Depression in Hemodialysis Patients
|
N/A | |
Completed |
NCT01063881 -
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
|
Phase 3 | |
Completed |
NCT00451165 -
Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery
|
N/A | |
Recruiting |
NCT04604951 -
Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury
|
N/A | |
Recruiting |
NCT04512287 -
PRP for Treatment of Peyronie's Disease
|
Phase 2 | |
Completed |
NCT02381912 -
Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
|
N/A | |
Completed |
NCT00698035 -
Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
|
Phase 2 | |
Completed |
NCT00443027 -
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
|
Phase 1 | |
Completed |
NCT00443248 -
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
|
Phase 1 | |
Completed |
NCT03241524 -
Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women
|
N/A | |
Terminated |
NCT03018106 -
Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
|
Phase 4 | |
Completed |
NCT04364841 -
Body Image and Sexuality After Bariatric Surgery
|
||
Completed |
NCT03592121 -
Study to Investigate the Effect of AB-101 in Breast Cancer Survivors
|
Early Phase 1 | |
Completed |
NCT00482664 -
The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
|
Phase 2 | |
Recruiting |
NCT05456919 -
Quality of Sexual Function in BRCA Mutated Women
|
||
Recruiting |
NCT06308614 -
Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women
|
Phase 2 |