Sexual DysfunctionPhase 3NCT00575328

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

A Phase 3 study testing Maca Root in people with Sexual Dysfunction and Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Sexual Dysfunction, Bipolar Disorder
What is being tested?: Maca Root
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 26 Feb 2008to 26 Apr 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is female, age 18 to 80 years
Subject has been on a steady regimen to treat bipolar disorder, including monotherapy with or any combination of antidepressants, mood stabilizers, atypical antipsychotics, or benzodiazepines, for at least 8 weeks; and is currently on a stable dose of that regimen for at least 4 weeks
Subject is currently euthymic (Hamilton-D scale score < 10) and is without significant anxiety symptoms (Hamilton-A < 10). Her bipolar disorder must be in remission (Young Mania Rating Scale score < 10)
Subject must have had no sexual dysfunction prior to taking psychotropic medications and there must be a clear temporal relationship between the sexual dysfunction and the treatment for bipolar disorder
Subject must have been consistently experiencing at least one of the following criteria for at least 4 weeks, with distress or disability:
Inability to have an orgasm, according to patient opinion

Show all 13Show fewer

Clinically significant orgasm delay with masturbation or intercourse
Inability to attain or maintain until completion of sexual activity an adequate lubrication swelling response of sexual excitement
Decreased libido according to patient opinion
Subject must be having or had been having some form of regular sexual activity (masturbation, oral sex, intercourse) at least twice monthly prior to the bipolar treatment regimen and is willing to continue efforts at sexual activity at least once weekly for the duration of the study
Subject must be in good general physical health
Subject must be able to understand and communicate in English
Subject must have given informed consent to participate in the study

Who cannot join

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

Show all 28Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females

Read the detailed description

The study seeks to enroll 80 patients with sexual dysfunction associated with their bipolar medication regimen over 24 months. Subjects were outpatient females between 18 and 80 years old with no significant symptoms of mania (Young Mania Rating Scale score<10), and who have been on a steady regimen of medications to treat bipolar disorder for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects will be randomly assigned in a double blind manner to receive 3000 mg/day of maca root or identical placebo for 12 weeks to determine whether maca root is more effective than placebo for the treatment of sexual dysfunction associated with treatment regimens for bipolar disorder.

Conditions: Sexual Dysfunction, Bipolar Disorder
Being tested: Maca Root, Placebo
Keywords: Sexual Dysfunction, Bipolar Disorder
Medical subject headings: Sexual Dysfunction, Physiological, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Maca RootDrug
Also called Lepidium
3g/day of Maca Root for 12 weeks.
PlaceboDrug
Also called Inactive placebo
Placebo provided by research pharmacy daily for 12 weeks.

Study groups in NCT00575328
Study group	Role	What they receive
Maca Root	Experimental	Subjects in this arm will be given 3g/day of Maca Root. Receives: Drug: Maca Root
Placebo	Placebo comparator	Subjects in this arm will receive inactive placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment.
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.
Measured: Biweekly from Baseline (week zero) to 12 weeks
Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment.
This instrument is composed of five items evaluating libido, sexual arousal or excitement, ability to achieve orgasm, ability to achieve and maintain an erection (for men only) and overall sexual satisfaction. Items are rated on a scale of 1 to 6 with a rating of 1 indicating greater than normal functioning and a rating of 6 indicating totally absent functioning. Possible total scores range from 5-30, with higher scores indicating greater pathology. Scores were obtained at baseline and at each biweekly assessment visit over 12 weeks of treatment.
Measured: Biweekly from Baseline (week zero) to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 200826 Apr 2010

First posted18 Dec 2007 (estimated)
Study start26 Feb 2008
Primary completion26 Apr 2010
Study completion26 Apr 2010

Why it stopped: Only N=8 subjects randomized; funding ran out; too small N to yield useful data.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Maca root will be compared against inactive placebo as a treatment for sexual dysfunction induced by psychotropic drugs.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00575328
Sponsor's protocol ID: 2007-P-001471
Status last verified: Sep 2020
First submitted: 14 Dec 2007
Last updated: 25 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No plan for data sharing at this time. Study was never completed and did not have enough subjects to yield useful data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females
ClinicalTrials.gov ID: NCT00575328
Acronym / sponsor ID: 2007-P-001471
Conditions: Sexual Dysfunction, Bipolar Disorder
Keywords: Sexual Dysfunction, Bipolar Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Only N=8 subjects randomized; funding ran out; too small N to yield useful data.
Enrolment: 8 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Alliance for Research on Schizophrenia and Depression
Study start: 26 Feb 2008 (actual)
Primary completion: 26 Apr 2010 (actual)
Study completion: 26 Apr 2010 (actual)
First posted: 18 Dec 2007 (estimated)
Results: Posted 7 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Maca root will be compared against inactive placebo as a treatment for sexual dysfunction induced by psychotropic drugs.

Arm	Type	Receives
Maca Root	Experimental	Drug: Maca RootSubjects in this arm will be given 3g/day of Maca Root.
Placebo	Placebo comparator	Drug: PlaceboSubjects in this arm will receive inactive placebo.

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subject is female, age 18 to 80 years
Subject has been on a steady regimen to treat bipolar disorder, including monotherapy with or any combination of antidepressants, mood stabilizers, atypical antipsychotics, or benzodiazepines, for at least 8 weeks; and is currently on a stable dose of that regimen for at least 4 weeks
Subject is currently euthymic (Hamilton-D scale score < 10) and is without significant anxiety symptoms (Hamilton-A < 10). Her bipolar disorder must be in remission (Young Mania Rating Scale score < 10)
Subject must have had no sexual dysfunction prior to taking psychotropic medications and there must be a clear temporal relationship between the sexual dysfunction and the treatment for bipolar disorder
Subject must have been consistently experiencing at least one of the following criteria for at least 4 weeks, with distress or disability:

Key exclusion criteria (28 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Maca RootAlso: Lepidium3g/day of Maca Root for 12 weeks.	Drug	Maca Root
PlaceboAlso: Inactive placeboPlacebo provided by research pharmacy daily for 12 weeks.	Drug	Placebo

Primary outcome

Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment.
Time frame: Biweekly from Baseline (week zero) to 12 weeks
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.
Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment.
Time frame: Biweekly from Baseline (week zero) to 12 weeks
This instrument is composed of five items evaluating libido, sexual arousal or excitement, ability to achieve orgasm, ability to achieve and maintain an erection (for men only) and overall sexual satisfaction. Items are rated on a scale of 1 to 6 with a rating of 1 indicating greater than normal functioning and a rating of 6 indicating totally absent functioning. Possible total scores range from 5-30, with higher scores indicating greater pathology. Scores were obtained at baseline and at each biweekly assessment visit over 12 weeks of treatment.

Results and safety

Results posted to the registry on 7 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maca Root	4	1
Placebo	4	2

Primary outcome: Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment.

Time frame: Biweekly from Baseline (week zero) to 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Maca Root n = 3	Placebo n = 3
ASEX-Baseline Score	23.7 (1.5)	21.3 (0.6)
ASEX-Final Score	23.3 (3.8)	23 (2.8)
ASEX-Change in Score	-0.3 (4.2)	1.5 (2.1)

Maca Root vs Placebo: Mean Difference (Final Values): 1.8 (95% CI -8.7 to 12.3), p = 0.62, t-test, 2 sided

Population analysed: Intent to treat sample. Subjects with at least one post baseline visit recorded with available data.

Primary outcome: Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment.

Time frame: Biweekly from Baseline (week zero) to 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Maca Root n = 3	Placebo n = 3
MGH-SD Score-Baseline	21 (2)	18.7 (2.3)
MGH-SD Score-Final	16.7 (5.0)	18 (1.7)
Change in MGH-SD Score	-4.3 (6.1)	-0.7 (2.1)

Maca Root vs Placebo: Mean Difference (Final Values): 3.6 (95% CI -6.7 to 13.97), p = 0.38, t-test, 2 sided

Population analysed: Intent to treat sample. Subjects with at least one post baseline visit recorded with available data.

Adverse events

Time frame: 2 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maca Root	1 of 4 (25%)	3 of 4 (75%)	0 of 4
Placebo	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Limitations and caveats (from the sponsor): Study was never completed due to low enrollment. Only 8 of a projected 80 subjects were randomized over a period of 2 years. Sample is too small to yield useful information.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plan for data sharing at this time. Study was never completed and did not have enough subjects to yield useful data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christina Dording, MD principal investigator

Massachusetts General Hospital

David Mischoulon, MD, PhD study director

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maca Root in people with Sexual Dysfunction and Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. (time frame: Biweekly from Baseline (week zero) to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00575328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.