Zestra in Women With Mixed Sexual Dysfunction

NCT00118495 | Completed Phase 3 DMC

• 1 other identifier: Z-04
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 13

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.

Conditions

Sexual Dysfunction, Psychological

Keywords

female sexual dysfunction; FSD; arousal; orgasm; desire; Zestra; Mixed FSD; Hypoactive sexual desire disorder; Sexual arousal disorder; Orgasmic disorder

Outcome Measures

Primary Outcomes (2)

• Safety: adverse events, physical examinations, clinical laboratory evaluations

• Female Sexual Function Index domain scores and totals

  Baseline to Visit 6 (12 weeks)

Secondary Outcomes (1)

• 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

Interventions

Non-prescription Zestra(TM): patented formulation DRUG

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QualiLife Pharmaceuticals: lead

Study Sites (13)

West Coast Clinical Research

Tarzana, California, 91356, United States

Location

Urology Research Options

Aurora, Colorado, 80012, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Center for Marital and Sexual Health of South Florida

West Palm Beach, Florida, 33401, United States

Location

Northeast Indiana Research

Fort Wayne, Indiana, 46825, United States

Location

Outpatient Clinical Research Facility

Indianapolis, Indiana, 46206-5250, United States

Location

Lahey Clinic

Peabody, Massachusetts, 01960, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

Hudson Valley Urology, PC

Poughkeepsie, New York, 12601, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Pelvic and Sexual Health Institute

Philadelphia, Pennsylvania, 19146, United States

Location

Urology San Antonio Research, PA

San Antonio, Texas, 78229, United States

Location

Midwest Research Specialists, LLC

Milwaukee, Wisconsin, 53209, United States

Location

Related Publications (1)

• 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.

  PMID: 12735087 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Orgasm

Condition Hierarchy (Ancestors)

Mental Disorders; Sexual Behavior; Behavior

Study Officials

• David M Ferguson, PhD, MD, FACCP

  Clinical Research Services Consulting

  STUDY DIRECTOR

• Julia R Heiman, PhD

  Kinsey Institute for Research in Sex, Gender and Reproduction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 11, 2005
• Study Start: March 1, 2006
• Study Completion: March 1, 2007
• Last Updated: July 6, 2007

Record last verified: 2007-07

Locations

US (13)