Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder

This study has been terminated.
(The investigator at Cedars stopped this study due to problems collecting payment from the sponsor.)
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00572377
First received: December 12, 2007
Last updated: June 19, 2008
Last verified: June 2008
  Purpose

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).


Condition Intervention Phase
Female Sexual Arousal Disorder
Drug: FemLife Gel
Drug: Placebo
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Female Sexual Encounter Profile (FSEP) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • standardized questionnaire [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572377

Locations
United States, California
Mark Goodson Building
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Ernst Schwarz, MD Cedars-Sinai Medical Center
  More Information

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.

Responsible Party: Ernst Schwarz MD, Cedars Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00572377     History of Changes
Other Study ID Numbers: IRB# 11268, FemLife
Study First Received: December 12, 2007
Last Updated: June 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Sexual
Arousal
Female

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Genital Diseases, Male
Genital Diseases, Female
Sexual and Gender Disorders
Mental Disorders
Alprostadil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014