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Zestra in Women With Mixed Sexual Dysfunction

Primary Purpose

Sexual Dysfunction, Psychological

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Non-prescription Zestra(TM): patented formulation
Sponsored by
QualiLife Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction, Psychological focused on measuring female sexual dysfunction, FSD, arousal, orgasm, desire, Zestra, Mixed FSD, Hypoactive sexual desire disorder, Sexual arousal disorder, Orgasmic disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females 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 follicle stimulating hormone [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. Exclusion Criteria: 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.

Sites / Locations

  • West Coast Clinical Research
  • Urology Research Options
  • South Florida Medical Research
  • Center for Marital and Sexual Health of South Florida
  • Northeast Indiana Research
  • Outpatient Clinical Research Facility
  • Lahey Clinic
  • Accumed Research Associates
  • Hudson Valley Urology, PC
  • MetroHealth Medical Center
  • The Pelvic and Sexual Health Institute
  • Urology San Antonio Research, PA
  • Midwest Research Specialists, LLC

Outcomes

Primary Outcome Measures

Safety: adverse events, physical examinations, clinical laboratory evaluations
Female Sexual Function Index domain scores and totals

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2005
Last Updated
July 4, 2007
Sponsor
QualiLife Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00118495
Brief Title
Zestra in Women With Mixed Sexual Dysfunction
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
QualiLife Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the clinical efficacy and safety of Zestra(TM) in women with acquired mixed desire/interest/arousal/orgasm disorders under conditions of home usage. The primary efficacy hypothesis will compare the effect of Zestra versus placebo on the incidence of "successful and satisfactory" sexual encounters.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Psychological
Keywords
female sexual dysfunction, FSD, arousal, orgasm, desire, Zestra, Mixed FSD, Hypoactive sexual desire disorder, Sexual arousal disorder, Orgasmic disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Non-prescription Zestra(TM): patented formulation
Primary Outcome Measure Information:
Title
Safety: adverse events, physical examinations, clinical laboratory evaluations
Title
Female Sexual Function Index domain scores and totals
Time Frame
Baseline to Visit 6 (12 weeks)
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females 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 follicle stimulating hormone [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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Ferguson, PhD, MD, FACCP
Organizational Affiliation
Clinical Research Services Consulting
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julia R Heiman, PhD
Organizational Affiliation
Kinsey Institute for Research in Sex, Gender and Reproduction
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Coast Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Urology Research Options
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Center for Marital and Sexual Health of South Florida
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Northeast Indiana Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Outpatient Clinical Research Facility
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46206-5250
Country
United States
Facility Name
Lahey Clinic
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Hudson Valley Urology, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
The Pelvic and Sexual Health Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Urology San Antonio Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Midwest Research Specialists, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12735087
Citation
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. doi: 10.1080/713847125.
Results Reference
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Zestra in Women With Mixed Sexual Dysfunction

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