Female Sexual Arousal DisorderPhase 1NCT00572377
Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder
A Phase 1 study testing FemLife Gel in people with Female Sexual Arousal Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Arousal Disorder
- What is being tested?
- FemLife Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Mar 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- FSAD based on American Foundation for Urological Disease Consensus Panel definition
- Post-menopausal by WISE criteria or proof of bilateral oophorectomy.
- FSAD for at least 6 months.
- History of self reported normal sexual arousal and/or orgasm in the past.
- Documentation of a normal PAP smear and pelvic exam within the past year.
- Women may be on hormone replacement therapy because this is a non-hormonal therapy.
Who cannot join
- Primary anorgasmia, vaginismus, sexual pain or sexual arousal disorder.
- History of unresolved sexual trauma or abuse.
- Endocrine disorders
- Chronic UTI, vaginal infection, pelvic inflammatory disease, or dyspareunia within the preceding 12 months.
- STI
- Clinically significant renal, hepatic, neurologic, or cardiac disease in the preceding 6 months.
- Male partner with impotence.
- Depression or other mood disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mark Goodson Building
Los Angeles, California, 90048
About this study
Official title: Safety and Efficacy of 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.
Read more
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).
- Conditions
- Female Sexual Arousal Disorder
- Being tested
- FemLife Gel, Placebo
- Keywords
- Sexual, Arousal, Female
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemLife GelDrug
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).
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| FemLife Gel | Active comparator | Not described Receives: Drug: FemLife Gel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Encounter Profile (FSEP)
Measured: 30 days
Secondary outcomes (1)
standardized questionnaire
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: The investigator at Cedars stopped this study due to problems collecting payment from the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Sexual Arousal DisorderStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ernst Schwarz, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572377
- Sponsor's protocol ID
- IRB# 11268
- Other IDs
- FemLife
- Status last verified
- Jun 2008
- First submitted
- 12 Dec 2007
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder
- ClinicalTrials.gov ID
- NCT00572377
- Acronym / sponsor ID
- IRB# 11268
- Conditions
- Female Sexual Arousal Disorder
- Keywords
- Sexual, Arousal, Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The investigator at Cedars stopped this study due to problems collecting payment from the sponsor.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FemLife Gel | Active comparator | Drug: FemLife Gel |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- FSAD based on American Foundation for Urological Disease Consensus Panel definition
- Post-menopausal by WISE criteria or proof of bilateral oophorectomy.
- FSAD for at least 6 months.
- History of self reported normal sexual arousal and/or orgasm in the past.
- Documentation of a normal PAP smear and pelvic exam within the past year.
Key exclusion criteria (8 listed)
- Primary anorgasmia, vaginismus, sexual pain or sexual arousal disorder.
- History of unresolved sexual trauma or abuse.
- Endocrine disorders
- Chronic UTI, vaginal infection, pelvic inflammatory disease, or dyspareunia within the preceding 12 months.
- STI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemLife Gelthe 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). | Drug | FemLife Gel |
| Placebothe 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). | Drug | Placebo |
Primary outcome
Female Sexual Encounter Profile (FSEP)
Time frame: 30 days
1 secondary outcome
standardized questionnaire
Time frame: 20 minutes
Results and safety
The study was stopped early (reason given: The investigator at Cedars stopped this study due to problems collecting payment from the sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
- Background1. 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.
Related trials for Female Sexual Arousal Disorder
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Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
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Not yet recruitingPhase 2
Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder
Female Sexual Arousal Disorder, Female Sexual Dysfunction (FSD)
Recruiting
Cognitive-Behavioural Couple Therapy for Sexual Interest/Arousal Disorder
Sexual Interest/Arousal Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernst Schwarz, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FemLife Gel in people with Female Sexual Arousal Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The investigator at Cedars stopped this study due to problems collecting payment from the sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Encounter Profile (FSEP) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00572377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2008.