Sexual Dysfunction MaleNCT05891327
Maca Extract in Sexual Dysfunction Male
A study testing Maca in people with Sexual Dysfunction Male, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Sexual Dysfunction Male
- What is being tested?
- Maca
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- evaluated as sexual dysfunction for more than three months by physician
- international index of erectile function (IIEF) score is less than or equal to 21
- erectile hardness score (EHS) score is less than or equal to 3
- aged over 18 years old
Who cannot join
- unable to cooperate with the course of the treatment
- suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs
- had Radical Prostatectomy (total removal of the prostate gland)
- suffering from active tumors in the prostate or pelvic area
- suffering from Hypogonadism
- anatomical deformation of the penis
Show all 12Show fewer
- men with penile prosthesis
- suffering from psychotic disorder (manic disorder, chronic depression, etc.)
- suffering from neurological diseases (multiple sclerosis, brain or spinal cord injuries, etc.)
- using Permanent pacemaker
- considered unsuitable to participate in this experiment according to the doctor
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lepidium Meyenii (Maca) Extract Supplementation on Male Sexual Funtion
The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion.
Read the detailed description
All participants performed anthropometric measurements, blood collection and questionnaire survey at 0-week. A random, double-blind design will be used to assign 60 participants into the experimental group (n = 30) or placebo group (n = 30). All participants consumed either 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks. The anthropometric measurements, blood samples, and questionnaire survey were collected again at 6-week, 12-week, 16-week, and 24-week. Data will be analyzed by two-way mixed design ANOVA.
- Conditions
- Sexual Dysfunction Male
- Being tested
- Maca, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacaDietary supplement
2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Maca group | Experimental | Not described Receives: Dietary Supplement: Maca |
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-5 score
Measured: Baseline (before supplementation)
IIEF-5 score
Measured: 6 weeks of supplementation
IIEF-5 score
Measured: 12 weeks of supplementation
IIEF-5 score
Measured: 18 weeks of supplementation
IIEF-5 score
Measured: 24 weeks of supplementation
EHS score
Measured: Baseline (before supplementation)
EHS score
Measured: 6 weeks of supplementation
EHS score
Measured: 12 weeks of supplementation
EHS score
Measured: 18 weeks of supplementation
EHS score
Measured: 24 weeks of supplementation
level of PSA
Measured: Baseline (before supplementation)
level of PSA
Measured: 6 weeks of supplementation
level of PSA
Measured: 12 weeks of supplementation
level of PSA
Measured: 18 weeks of supplementation
level of PSA
Measured: 24 weeks of supplementation
Testosterone level
Measured: Baseline (before supplementation)
Testosterone level
Measured: 6 weeks of supplementation
Testosterone level
Measured: 12 weeks of supplementation
Testosterone level
Measured: 18 weeks of supplementation
Testosterone level
Measured: 24 weeks of supplementation
LH level
Measured: Baseline (before supplementation)
LH level
Measured: 6 weeks of supplementation
LH level
Measured: 12 weeks of supplementation
LH level
Measured: 18 weeks of supplementation
LH level
Measured: 24 weeks of supplementation
Level of FSH
Measured: Baseline (before supplementation)
Level of FSH
Measured: 6 weeks of supplementation
Level of FSH
Measured: 12 weeks of supplementation
Level of FSH
Measured: 18 weeks of supplementation
Level of FSH
Measured: 24 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study startDec 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Dysfunction MaleStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891327
- Sponsor's protocol ID
- N202303063
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lepidium Meyenii (Maca) Extract Supplementation on Male Sexual Funtion
- ClinicalTrials.gov ID
- NCT05891327
- Acronym / sponsor ID
- N202303063
- Conditions
- Sexual Dysfunction Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion.
Detailed description
All participants performed anthropometric measurements, blood collection and questionnaire survey at 0-week. A random, double-blind design will be used to assign 60 participants into the experimental group (n = 30) or placebo group (n = 30). All participants consumed either 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks. The anthropometric measurements, blood samples, and questionnaire survey were collected again at 6-week, 12-week, 16-week, and 24-week. Data will be analyzed by two-way mixed design ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)
| Arm | Type | Receives |
|---|---|---|
| Maca group | Experimental | Dietary Supplement: Maca |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- evaluated as sexual dysfunction for more than three months by physician
- international index of erectile function (IIEF) score is less than or equal to 21
- erectile hardness score (EHS) score is less than or equal to 3
- aged over 18 years old
Key exclusion criteria (12 listed)
- unable to cooperate with the course of the treatment
- suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs
- had Radical Prostatectomy (total removal of the prostate gland)
- suffering from active tumors in the prostate or pelvic area
- suffering from Hypogonadism
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 |
|---|---|---|
| Maca2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks | Dietary supplement | Maca group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
IIEF-5 score
Time frame: Baseline (before supplementation)
IIEF-5 score
Time frame: 6 weeks of supplementation
IIEF-5 score
Time frame: 12 weeks of supplementation
IIEF-5 score
Time frame: 18 weeks of supplementation
IIEF-5 score
Time frame: 24 weeks of supplementation
EHS score
Time frame: Baseline (before supplementation)
EHS score
Time frame: 6 weeks of supplementation
EHS score
Time frame: 12 weeks of supplementation
EHS score
Time frame: 18 weeks of supplementation
EHS score
Time frame: 24 weeks of supplementation
level of PSA
Time frame: Baseline (before supplementation)
level of PSA
Time frame: 6 weeks of supplementation
level of PSA
Time frame: 12 weeks of supplementation
level of PSA
Time frame: 18 weeks of supplementation
level of PSA
Time frame: 24 weeks of supplementation
Testosterone level
Time frame: Baseline (before supplementation)
Testosterone level
Time frame: 6 weeks of supplementation
Testosterone level
Time frame: 12 weeks of supplementation
Testosterone level
Time frame: 18 weeks of supplementation
Testosterone level
Time frame: 24 weeks of supplementation
LH level
Time frame: Baseline (before supplementation)
LH level
Time frame: 6 weeks of supplementation
LH level
Time frame: 12 weeks of supplementation
LH level
Time frame: 18 weeks of supplementation
LH level
Time frame: 24 weeks of supplementation
Level of FSH
Time frame: Baseline (before supplementation)
Level of FSH
Time frame: 6 weeks of supplementation
Level of FSH
Time frame: 12 weeks of supplementation
Level of FSH
Time frame: 18 weeks of supplementation
Level of FSH
Time frame: 24 weeks of supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maca in people with Sexual Dysfunction Male, run by Taipei Medical University at 1 site in Taiwan.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Ta Yang, Doctorate (886-2-27361661 ext. 2275, yangrugby@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-5 score (time frame: Baseline (before supplementation)). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2023.