Zestra in Women With Mixed Sexual Dysfunction

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QualiLife Pharmaceuticals

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.