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).
1. FSAD based on American Foundation for Urological Disease Consensus Panel definition
2. Post-menopausal by WISE criteria or proof of bilateral oophorectomy.
3. FSAD for at least 6 months.
4. History of self reported normal sexual arousal and/or orgasm in the past.
5. Documentation of a normal PAP smear and pelvic exam within the past year.
6. Women may be on hormone replacement therapy because this is a non-hormonal therapy.
1. Primary anorgasmia, vaginismus, sexual pain or sexual arousal disorder.
2. History of unresolved sexual trauma or abuse.
3. Endocrine disorders
4. Chronic UTI, vaginal infection, pelvic inflammatory disease, or dyspareunia within
the preceding 12 months.
6. Clinically significant renal, hepatic, neurologic, or cardiac disease in the
preceding 6 months.
7. Male partner with impotence.
8. Depression or other mood disorder.