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NCT00575328 · ClinicalTrials.gov registry record · Phase 3
Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 8
- Enrollment target
NCT00575328: Clinical Trial Phase 3 study, sponsored by Massachusetts General Hospital.
NCT00575328 is a Phase 3 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 8 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00575328, a Phase 3 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
The ASEX scale consists of five items rating sexual drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. The range of total score is from 5-30, with the higher scores indicating greater sexual dysfunction. Scores were obtained at baseline and at all biweekly assessment visits over the 12 weeks of treatment.
Interventions
- DRUG Placebo
- DRUG Maca Root
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-02-26 |
| Est. Completion | 2010-04-26 |
| Phase | Phase 3 |
Why NCT00575328 stopped before completion
NCT00575328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00575328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00575328 about?
NCT00575328 is a clinical study titled "Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females". 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 effe...
What is the current status of trial NCT00575328?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 8 participants. The study started on 2008-02-26. Estimated completion is 2010-04-26.
What interventions are being tested in trial NCT00575328?
The interventions under investigation include: Placebo (DRUG), Maca Root (DRUG).
Who is sponsoring clinical trial NCT00575328?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00575328's enrollment target sits among peer trials
8 1993rd of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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