Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females

Exclusion Criteria

• •Primary or prior diagnosis of a sexual disorder (other than the side effect of the bipolar medication or symptom of the bipolar disorder)
• •Sexual dysfunction secondary to general underlying medical condition
• •Penile, vaginal, clitoral or other sexual organ anatomical deformities
• •Any uncontrolled psychiatric disorder
• •Alcohol or substance abuse or dependence within the past six months
• •Recent major relationship changes, disruption, or turmoil ongoing or anticipated which are unrelated to her sexual dysfunction
• •Blood pressure outside the range of 90/50 - 170/100
• •Known hyperprolactinemia
• •Use of investigational drugs within previous 3 months or during study
• •Current use of other drugs for sexual dysfunction or other therapies or medications to treat sexual dysfunction
• •Current use of nefazodone
• •Hormone replacement therapy, unless patient has been on stable dose of hormone therapy for at least 3 mo prior to the bipolar treatment regimen and had no sexual dysfunction while on the same hormone therapy regimen, and there is no change in the hormone replacement therapy during the study
• •Pregnancy, lactating, or planning to become pregnant during the study
• •Child bearing potential subjects unwilling and/or not prepared and/or who are judged unreliable to use an acceptable and verifiable form of contraception during the study
• •Any clinically significant abnormality on the screening physical examination
• •History of hormonal cancers
• •Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study, or that may increase the risk to subjects or others as a result of participating in this study
• •Dyspareunia secondary to an inflammatory or anatomical condition
• •Prior use of maca for at least two weeks
• •Infection of the urogenital tract that may make sexual activity painful or difficult
• •Subjects whose sexual partners are suffering from and/or receiving treatment for sexual dysfunction
• •Receiving psychosexual or other therapy for sexual dysfunction and not willing to discontinue that treatment at screening
• •Subjects who do not understand and communicate in English
• •Subjects for whom sexual activity is inadvisable
• •Subjects whose sexual dysfunction is considered to be situational
• •Subjects not attempting some form of regular sexual activity at least twice monthly and at least once weekly during study visit intervals for duration of entire study
• •Changes in bipolar medication and/or dose of medication within the last 4 weeks before baseline visit
• •Participants on medications with a narrow therapeutic window or low therapeutic index for which small variations may be harmful given the lack of systematic experience with drug-supplement interactions (i.e. - cyclosporine, digoxin, warfarin, and antiretrovirals)