Zestra in Women with Mixed Sexual Dysfunction - Article
Clinical Trial: Zestra in Women with Mixed Sexual Dysfunction
This study is not yet open for patient recruitment.
|Hypoactive Sexual Desire Disorder |
Sexual Arousal Disorder
| Drug: Non-prescription Zestra (TM): patented formulation ||Phase III |
MedlinePlus related topics: Female Sexual Dysfunction
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial of the Efficacy and Safety of Zestra(TM) in Women with Mixed Desire/Interest/Arousal/Orgasm Disorders
Secondary Outcomes: Efficacy: incidences for remaining FSEP© questions, FSFI© (all domains), FSDS©, global assessment questions, WITS©, QCTS©, Beck Depression Inventory, Dyadic Adjustment Scale, sexual encounter frequency, drop out rates
Expected Total Enrollment: 200
This Phase 3 study is being conducted to evaluate the efficacy and safety of Zestra(TM) compared to a placebo oil in women diagnosed as having acquired mixed interest/desire/arousal/orgasm disorders with varying presentations of each component in conditions of home use in conjunction with sexual activities. The study is a randomized, placebo-controlled, double-blind, parallel design trial. After subject screening, there is an open-label, placebo run-in period of four weeks, followed by a double-blinded 12 week treatment period. This design is consistent with the Paris 2003 recommendations for female sexual dysfunction (FSD) clinical trials and the Food and Drug Administration (FDA) Guidance on Clinical Development of Products for the Treatment of Female Sexual Dysfunction although the duration of active treatment in this study is 12 weeks rather than the 6 months suggested by the FDA for Phase 3 studies.
Primary efficacy assessment will be the subjects’ assessments of “successful and satisfactory” sexual encounters as recorded in a diary (question 10 in the Female Sexual Encounter Profile [FSEP©]). Secondary evaluations of efficacy will include the other FSEP questions, a subject self-assessment questionnaire (Female Sexual Function Index [FSFI©]), two global assessment questions, a treatment satisfaction questionnaire (WITS©), the Beck Depression Inventory, the Dyadic Adjustment Scale (DAS), a consumer testing survey (QualiLife Consumer Testing Survey [QCTS©]), and a distress scale (Female Sexual Distress Scale [FSDS©]), sexual encounter frequency, and drop-out rates.
The selection of outcome measures in this study is based on the most current information available. The FSEP© has been used in many FSD studies and specifically meets the FDA recommendations for a primary outcome measure. The initial validation study of the FSEP© was presented at the 11th World Congress of the International Society for Sexual and Impotence Research in Buenos Aires in 2004. The FSFI©, the FSDS©, and global assessment questions are routinely used in FSD trials, and the first two have been subjects of ongoing validation for a number of years. Global assessment questions have historically been used to calculate response rates. The QCTS© is a consumer testing survey which addresses issues ultimately impinging on product marketability. WITS© is a female oriented treatment satisfaction instrument newly developed by Stanley E. Althof, Ph.D., Eric W. Corty, Ph.D., and Miki Wieder, M.A., 2004; the authors’ authorized use of this instrument in this study is part of the ongoing validation for this questionnaire. Since depression can contribute to FSD and FSD can contribute to depression, seriously confounding diagnostic and treatment schema, the commonly used Beck Depression Inventory will be administered at the end of the baseline run-in period and then at the end of the double-blinded treatment period. Relational factors have the same confounding issues as depression; thus, the participants’ attitudes about their relationships with their partners will be assessed at baseline and end of treatment using the Dyadic Adjustment Scale. Sexual encounter frequency may prove a useful outcome measure since a beneficial effect of treatment may be reinforcing, while lack of efficacy by the placebo may be discouraging. A similar hypothesis is the basis of drop-out analysis.
- Female 21 to 65 years of age.
- Have been previously “functional” or experienced sexual desire/arousal/orgasm for several years in the past.
- Postmenopausal (no menses for one year and appropriate elevation of FSH), or using hormonal contraception for at least 3 months prior to study entry, or have had a tubal ligation at least 3 months prior to study entry or confining all sexual intercourse to a vasectomized partner.
- Provide written informed consent.
- Have a stable heterosexual relationship with a male partner for at least 1 year. Partner must attend screening visit and also sign a separate informed consent form.
- Have a partner score of "not impotent" or "minimally impotent" on the Single Question Assessment of Erectile Dysfunction. The subject will determine the partner score privately.
- Willing to engage in sexual activities with intent to attain orgasm at least 2 times per week.
- Meet the diagnostic criteria for one or more of the following acquired disorders: *Women’s sexual interest/desire disorder; *Subjective sexual arousal disorder; *Combined genital and subjective arousal disorder; *Genital sexual arousal disorder; *Women’s orgasmic disorder.
- Have a score of > 15 on the FSDS .
- Willing and able to understand and comply with all study requirements.
- Evidence of unresolved sexual trauma or abuse.
- Primary anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder.
- Female sexual dysfunction caused by untreated endocrine disease, e.g., hypopituitarism, hypothyroidism, diabetes mellitus.
- Pregnant or nursing.
- Sensitivity to any of the ingredients in Zestra for Women(TM).
- Chronic or complicated urinary tract or vaginal infections within previous 12 months.
- Pelvic inflammatory disease within previous 12 months.
- Currently active sexually transmitted disease.
- Chronic dyspareunia not attributable to vaginal dryness within previous 12 months.
- Currently active moderate to severe vaginitis.
- Cervical dysplasia within previous 12 months.
- Significant cervicitis as manifested by mucopurulent discharge from the cervix.
- Significant gynecologic conditions such as uterine fibroids, vulvar vestibulitis, or vaginismus that may (in the investigator’s opinion) interfere with the subject’s ability to comply with study procedures.
- Psychoses and bipolar disorder.
- Use of neuroleptics or lithium within previous 3 months.
- Unwillingness to forego any medications, herbal treatments, or dietary supplements intended to enhance sexual function during the course of the study.
- History of myocardial infarction within previous 6 months.
- History or evidence of significant renal or hepatic disease within previous 6 months.
- Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc.
- Unwillingness to omit cunnilingus from sexual activities during the study. No post-coital fellatio allowed.
- Any condition which, in the Investigator’s opinion, would interfere with the subject’s ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results.
- Any condition which would endanger the participant if she participated in this trial.
Location and Contact Information
West Coast Clinical Research, Tarzana, California, 91356, United States
Eugene Dula, MD, FACS, Principal Investigator
South Orange County Medical Research Center, Laguna Hills, California, 92637, United States
Jay Young, MD, Principal Investigator
Urology Research Options, Aurora, Colorado, 80012, United States
Joel M Kaufman, MD, Principal Investigator
South Florida Medical Research, Aventura, Florida, 33180, United States
Marc C Gittelman, MD, FACS, Principal Investigator
Kinsey Institute, Bloomington, Indiana, 47405-7686, United States
Northeast Indiana Research, Fort Wayne, Indiana, 46825, United States
Christopher P Steidle, MD, Principal Investigator
Sexual Wellness Center, Annapolis, Maryland, 21401, United States
Andrew T Goldstein, MD, Principal Investigator
Lahey Clinic, Peabody, Massachusetts, 01960, United States
Andre T Guay, MD, FACP, FACE, Principal Investigator
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08901, United States
Mercedes (Fran) Christ, RN, APN, C 732-235-7292 email@example.com
Gloria Bachmann, MD, Principal Investigator
Sandra Leiblum, PhD, Sub-Investigator
Columbia-Presbyterian Medical Center, New York, New York, 10032, United States
Ridwan Shabsigh, MD, Principal Investigator
Accumed Research Associates, Garden City, New York, 11530, United States
Mitchell D Efros, MD, FACS, Principal Investigator
Hudson Valley Urology, PC, Poughkeepsie, New York, 12601, United States
Evan R Goldfischer, MD, Principal Investigator
MetroHealth Medical Center, Cleveland, Ohio, 44109, United States
Robert T Segraves, MD, PhD, Principal Investigator
The Pelvic and Sexual Health Institute, Philadelphia, Pennsylvania, 19146, United States
Kristene E Whitmore, MD, Principal Investigator
Susan Kellogg Spadt, PhD, CRNP, Sub-Investigator
Urology San Antonio Research, PA, San Antonio, Texas, 78229, United States
Timothy C Hlavinka, MD, Principal Investigator
Midwest Research Specialists, LLC, Milwaukee, Wisconsin, 53209, United States
Mitchell L Wiatrak, MD, CCRI, Principal Investigator
David M Ferguson, PhD, MD, FACCP, Study Director, Clinical Research Services Consulting
Julia R Heiman, PhD, Principal Investigator, Kinsey Institute for Research in Sex, Gender and Reproduction
Ferguson DM, Steidle CP, Singh GS, Alexander JS, Weihmiller MK, Crosby MG. Randomized, placebo-controlled, double blind, crossover design trial of the efficacy and safety of Zestra for Women in women with and without female sexual arousal disorder. J Sex Marital Ther. 2003;29 Suppl 1:33-44.
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 8, 2005
ClinicalTrials.gov Identifier: NCT00118495
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26