drugset / Trial / NCT00575328

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

NCT00575328 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this research study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by the treatment for bipolar disorder. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes. We suspect that Maca Root will result in a significant reduction in sexual dysfunction when compared to a placebo group.

Timeline

Start
2008-02-26
Primary completion
2010-04-26
Completion
2010-04-26

Outcome

Missed primary endpoint

Stopped (Business): “Only N=8 subjects randomized; funding ran out; too small N to yield useful data.”

registry analysis (superiority test); Maca Root vs Placebo; p = 0.62; NCT00575328 ↗

registry analysis (superiority test); Maca Root vs Placebo; p = 0.38; NCT00575328 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Maca Root Unknown 3000 mg —