Zestra in Women With Mixed Sexual Dysfunction (NCT00118495) | Clinical Trial Compass
CompletedPhase 3
Zestra in Women With Mixed Sexual Dysfunction
United States200 participantsStarted 2006-03
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexFEMALE
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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 av…