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 range
21 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.