A Phase 1 interventional study of FemLife Gel and Placebo in Female Sexual Arousal Disorder, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-20.
Sponsored by Cedars-Sinai Medical Center · Phase 1, Interventional, and Treatment
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).
115 studies on the registry are indexed under Sexual Dysfunction, Physiological; 46 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 80 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: FemLife Gel
Drug: 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).
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).
Female Sexual Encounter Profile (FSEP)
Time frame: 30 days
standardized questionnaire
Time frame: 20 minutes
This study is terminated, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sexual Dysfunction, Physiological→
Cedars-Sinai Medical Center