Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder
Female sexual arousal disorder (FSAD) is a frequent finding in women in middle age and more prevalent in post-menopausal women. Topical alprostadil is currently under development for the treatment of FSAD. The purpose of this research is to determine if this formula of alprostadil is safe and effective in women with FSAD. We will be comparing alprostadil to placebo. Each participant will be treated for 1 month with active alprostadil and 1 month with placebo without knowing which they are using. This way, the investigators can compare the effects of alprostadil to the effects of an inactive topical gel.
Post-menopausal women with FSAD will be recruited. The women interested in participating in the study will first meet with investigators and answer questions to make sure they are eligible for the study and fit the diagnosis of FSAD.
Once enrolled, subjects will fill out questionnaires about their medical history, social history, and psychosocial history. They will also undergo medical examination. At this introductory research visit they will fill out baseline questionnaires, give medical history, undergo physical exam and have blood drawn. The informed consent will be reviewed and will be signed by the participant at this time.
The subject will then return for the 1st treatment visit at which time vital signs like blood pressure and heart rate will be taken, external genitalia will be examined and study drug will be dispensed after randomly being assigned to either alprostadil or placebo. After instruction, the subject will use first dose in the clinic and be monitored for 2 hours looking for changes in vital signs or local genitalia reaction. If no problems are noted, subject will be sent home with study drug and Female Sexual Encounter Profile Cards (FSEP). The patient will fill out these cards with each sexual encounter. After 1 week patient will be contacted by phone and asked about side effects or concerns. After 4 weeks the subject will return for another study visit at which time FSEP cards and left over study drug will be collected, questionnaires will be filled out, labs will be drawn and subject will undergo exam of external genitalia. The subject will then be sent home for a 2 week washout period.
The subject will return after this 2 week period with no study medication; she will then return and the above process will be repeated with either alprostadil or placebo (whichever she did not receive the first time).
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder|
- Female Sexual Encounter Profile (FSEP) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- standardized questionnaire [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: FemLife Gel||
Drug: FemLife Gel
the gel or placebo (240 mcg)applied to the vagina; 20 doses to be used over the 30 day period and to complete the Female Sexual Encounter Profile (FSEP).
|Placebo Comparator: Placebo||
the gel or placebo (240 mcg) applied to the vagina; 20 doses to be used over the 30 day period and to complete the Female Sexual Encounter Profile (FSEP).
|United States, California|
|Mark Goodson Building|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Ernst Schwarz, MD||Cedars-Sinai Medical Center|