Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder
NCT ID: NCT00572377
Last Updated: 2008-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
10 participants
INTERVENTIONAL
2007-05-31
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FemLife Gel
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
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
5. STI
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.
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cedars-Sinai Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cedars Sinai Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ernst Schwarz, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mark Goodson Building
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
1. Basson R. Clinical practice. Sexual desire and arousal disorders in women. N Engl J Med. 2006;354:1497-506. 2. Addis IB et al. Reproductive Risk Factors for Incontinence Study at Kaiser Study Group. Sexual activity and function in middle-aged and older women. Obstet Gynecol. 2006;107:755-64. 3. Heiman JR et al. Topical alprostadil (PGE1) for the treatment of female sexual arousal disorder: in-clinic evaluation of safety and efficacy. J Psychosom Obstet Gynaecol. 2006;27:31-41 4. Kielbasa LA et al. Topical Alprostadil Treatment of Female Sexual Arousal Disorder Ann Pharmacother. 2006 Jun 6; [Epub ahead of print]. 5. Padma-Nathan H et al. Efficacy and Safety of Topical Alprostadil Cream for the Treatment of Female Sexual Arousal Disorder: A Double-Blind, Multicenter, Randomized, and Placebo-Controlled Clinical Trial. J of Sex and Marital Therapy. 29: 329-344, 2003.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FemLife
Identifier Type: -
Identifier Source: secondary_id
IRB# 11268
Identifier Type: -
Identifier Source: org_study_id