Sexual Dysfunction, PhysiologicalPhase 1macaNCT02624648
Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women
A Phase 1 study testing The Female Sexual Function Index (FSFI), The Female Intervention Efficacy Index (FIEI) and The Beck Depression Inventory II in people with Sexual Dysfunction, Physiological, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
Objective: To study the effects of Lepidium Meyenii in sexual function of postmenopausal women. Method: It will be held a clinical, prospective, randomized, double-blind, placebo-controlled study with 144 postmenopausal women with sexual dysfunction, treated at Menopause Clinic at the Faculty of Medical Sciences of… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Physiological
- What is being tested?
- The Female Sexual Function Index (FSFI), The Female Intervention Efficacy Index (FIEI) and The Beck Depression Inventory II
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Dec 2016
- Phase
- Phase 1
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The postmenopausal women with full autonomy, with one year or more of amenorrhea and follicle stimulating hormone (FSH) > 30 milli-International unit/mL
- Women who are not regularly practicing sexual activity will be included because the desire domain is subject to the same evaluation in this situation
- Estrogen and progesterone were permitted if the dose had been stable for six months prior to screening
Who cannot join
- Cardiac, renal and hepatic diseases
- Diabetes mellitus
- Cognitive disorders
- Hormone-dependent tumor
- History of psychiatric illness current and/or past, regular use of two or more doses of alcohol by day (dose = 12 grams of pure alcohol, which corresponds to 330 mL of beer, 100 mL wine, 30 mL of distilled World Health Organization standard dose) leading to impairment or clinically significant distress (DSM-5)
- Consumption of Maca supplements or any other nutritional supplement known to cause changes in sexual function
Show all 17Show fewer
- Use of any drug that, in the opinion of the investigator, may affect sexual function or any of the following medications: anti-epileptics, cytochrome P450 isoform 3A4 (CYP3A4) inducers
- Dopamine agonists and other parkinsonian drugs
- Metoclopramide
- Androgens and antiandrogens, the anti-oestrogens
- Fluoxetine or any hormonal implant long-acting in 30 days before the exam
- Analogues of gonadotropin-releasing hormone and other hormones and inhibitors
- Benzodiazepines prescribed for insomnia
- Sedatives and hypnotics
- Antidepressants
- Antipsychotics, mood stabilizers, narcotics (except when used to relieve short-term pain),
- Lubricants/moisturizers that contain substances that promote heating and/or vaginal stimulators
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Vale Do Sapucai University (Univas)
Pouso Alegre, Minas Gerais, 37550-000
BENEDITO F REIS, PROF, 553599844648, benefabiano@uol.com.br
SONIA MARIA R ROSA LIMA, PROF, 5511971519229, lima@silber.com.br
About this study
Official title: Effects of Lepidium Meyenii Walp (Peruvian Maca) on Sexual Function in Postmenopausal
Objective: To study the effects of Lepidium Meyenii in sexual function of postmenopausal women.
Method: It will be held a clinical, prospective, randomized, double-blind, placebo-controlled study with 144 postmenopausal women with sexual dysfunction, treated at Menopause Clinic at the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai University. All women sign the Consent Form Term. The study will be conducted in accordance with the protocol and principles of the Declaration Helsinki (Version 1996), according to International Conference on Harmonization and Tripartite Guidelines for good clinical practice and regulatory requirements. The protocol was approved by the Ethics Committee of the Faculty of Medical Sciences of Santa Casa de São Paulo.
Hypothesis: It is expected to be an improvement of sexual function in postmenopausal women.
Read the detailed description
It will be a prospective, randomized, double-blind, placebo-controlled study with 144 postmenopausal women with sexual dysfunction, met in Menopause Clinic at the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai University. All women signed the Informed Consent. The study will be conducted in accordance with the protocol and principles set out in Declaration of Helsinki (1996 version), according to International Conference on Harmonization and Tripartite Guidelines for good practice clinics and applicable regulatory requirements.
The protocol was submitted and approved by the Ethics Committee, Faculty of Medical Sciences Committee Santa Casa de São Paulo. The diagnosis of sexual dysfunction will be done by a sexologist physician experienced and trained in the diagnosis of female sexual disorders through a structured clinical interview, a list of sexual symptoms. It will be oriented to avoid further consumption of diet or another type of herbal medicine during the study. After the interview, signing the Informed Consent and they will be informed about the randomization. Interview with sexological questionnaires will be applied used in Sexology Clinic, Faculty of Medical Sciences of Santa Casa de São Paulo and Vale do Sapucai University, with the purpose of obtaining data sociodemographic. The Female Sexual function Index (FSFI) and the Female Intervention Efficacy Index questionnaire (FIEI). When necessary, the Beck Depression Inventory II (Cunha 2001) will be used to ward off depression, which will be applied by enabled professional. The application will be individually and by the same researcher. The results will be analyzed and interpreted in the light of the theoretical framework of socio-historical psychology, this theory of knowledge, is associated with the understanding of the culture of the structure, social organization and the rescue human subjectivity.
- Conditions
- Sexual Dysfunction, Physiological
- Being tested
- The Female Sexual Function Index (FSFI), The Female Intervention Efficacy Index (FIEI), The Beck Depression Inventory II, Lepidium Meyenii Walp, Placebo
- Keywords
- Sexual Dysfunction, Postmenopausal women, Sexual desire
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Female Sexual Function Index (FSFI)Behavioural
The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function
The Female Intervention Efficacy Index (FIEI)Behavioural
The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function
The Beck Depression Inventory IIBehavioural
The Beck Depression Inventory II will be used to evaluate or ward off depression
Lepidium Meyenii WalpDrug
Also called Maca
They will receive a capsule of Lepidium Meyenii Walp twice a day for 120 days
PlaceboDrug
They will receive a capsule of Placebo twice a day for 120 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | The effects of Placebo on sexual function, desire and depression in postmenopausal women.
The Female Sexual Function Index (FSFI) and the Female Intervention Efficacy Index Questionnaire (FIEI).
The Beck Depression Inventory II will be used to ward off depression Receives: Behavioral: The Female Sexual Function Index (FSFI); Behavioral: The Female Intervention Efficacy Index (FIEI); Behavioral: The Beck Depression Inventory II; Drug: Placebo |
| Maca (Lepidium Meyenii Walp) Group | Experimental | The effects of Lepidium Meyenii Walp on sexual function, desire and depression in postmenopausal women.
The Female Sexual Function Index (FSFI) and the Female Intervention Efficacy Index Questionnaire (FIEI).
The Beck Depression Inventory II will be used to ward off depression Receives: Behavioral: The Female Sexual Function Index (FSFI); Behavioral: The Female Intervention Efficacy Index (FIEI); Behavioral: The Beck Depression Inventory II; Drug: Lepidium Meyenii Walp |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSFI Questionnaire to evaluate the sexual function
To study the effects of Lepidium meyenii and placebo on sexual function in postmenopausal women
Measured: 120 days
Secondary outcomes (1)
FIEI Questionnaire to evaluate the sexual desire
To study the effects of Lepidium meyenii and placebo on sexual desire in postmenopausal women
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Sexual Dysfunction, PhysiologicalStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Responsible party
- Principal investigator, Benedito Fabiano dos Reis, Universidade do Vale do Sapucai
- Investigators
- Fabiola SM Campos, MD, Study director, Universidade do Vale do SapucaiSonia Maria R Rosa Lima, PhD, Principal investigator, Santa Casa of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624648
- Sponsor's protocol ID
- CAAE 43373915.3.0000.5479
- Acronym
- maca
- Status last verified
- Jun 2016
- First submitted
- 30 Nov 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dailey RK, Neale AV, Northrup J, West P, Schwartz KL. Herbal product use and menopause symptom relief in primary care patients: a MetroNet study. J Womens Health (Larchmt). 2003 Sep;12(7):633-41. doi: 10.1089/154099903322404285.
PubMed 14583104Geller SE, Studee L. Botanical and dietary supplements for menopausal symptoms: what works, what does not. J Womens Health (Larchmt). 2005 Sep;14(7):634-49. doi: 10.1089/jwh.2005.14.634.
PubMed 16181020Kronenberg F, Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002 Nov 19;137(10):805-13. doi: 10.7326/0003-4819-137-10-200211190-00009.
PubMed 12435217van der Sluijs CP, Bensoussan A, Liyanage L, Shah S. Women's health during mid-life survey: the use of complementary and alternative medicine by symptomatic women transitioning through menopause in Sydney. Menopause. 2007 May-Jun;14(3 Pt 1):397-403. doi: 10.1097/01.gme.0000236937.36078.f4.
PubMed 17202872Minelli C, Abrams KR, Sutton AJ, Cooper NJ. Benefits and harms associated with hormone replacement therapy: clinical decision analysis. BMJ. 2004 Feb 14;328(7436):371. doi: 10.1136/bmj.328.7436.371.
PubMed 14962874Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. doi: 10.1016/j.amjmed.2005.09.044.
PubMed 16414334Chung F, Rubio J, Gonzales C, Gasco M, Gonzales GF. Dose-response effects of Lepidium meyenii (Maca) aqueous extract on testicular function and weight of different organs in adult rats. J Ethnopharmacol. 2005 Apr 8;98(1-2):143-7. doi: 10.1016/j.jep.2005.01.028.
PubMed 15763375Meissner HO, Kapczynski W, Mscisz A, Lutomski J. Use of gelatinized maca (lepidium peruvianum) in early postmenopausal women. Int J Biomed Sci. 2005 Jun;1(1):33-45.
PubMed 23674952Gonzales GF, Cordova A, Gonzales C, Chung A, Vega K, Villena A. Lepidium meyenii (Maca) improved semen parameters in adult men. Asian J Androl. 2001 Dec;3(4):301-3.
PubMed 11753476Gonzales GF, Ruiz A, Gonzales C, Villegas L, Cordova A. Effect of Lepidium meyenii (maca) roots on spermatogenesis of male rats. Asian J Androl. 2001 Sep;3(3):231-3.
PubMed 11561196Gonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez C, Castillo S. Effect of Lepidium meyenii (MACA) on sexual desire and its absent relationship with serum testosterone levels in adult healthy men. Andrologia. 2002 Dec;34(6):367-72. doi: 10.1046/j.1439-0272.2002.00519.x.
PubMed 12472620Gonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez C. Effect of Lepidium meyenii (Maca), a root with aphrodisiac and fertility-enhancing properties, on serum reproductive hormone levels in adult healthy men. J Endocrinol. 2003 Jan;176(1):163-8. doi: 10.1677/joe.0.1760163.
PubMed 12525260Gonzales GF, Gasco M, Cordova A, Chung A, Rubio J, Villegas L. Effect of Lepidium meyenii (Maca) on spermatogenesis in male rats acutely exposed to high altitude (4340 m). J Endocrinol. 2004 Jan;180(1):87-95. doi: 10.1677/joe.0.1800087.
PubMed 14709147Gonzales GF, Miranda S, Nieto J, Fernandez G, Yucra S, Rubio J, Yi P, Gasco M. Red maca (Lepidium meyenii) reduced prostate size in rats. Reprod Biol Endocrinol. 2005 Jan 20;3:5. doi: 10.1186/1477-7827-3-5.
PubMed 15661081Oshima M, Gu Y, Tsukada S. Effects of Lepidium meyenii Walp and Jatropha macrantha on blood levels of estradiol-17 beta, progesterone, testosterone and the rate of embryo implantation in mice. J Vet Med Sci. 2003 Oct;65(10):1145-6. doi: 10.1292/jvms.65.1145.
PubMed 14600359
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lepidium Meyenii Walp (Peruvian Maca) on Sexual Function in Postmenopausal
- ClinicalTrials.gov ID
- NCT02624648
- Acronym / sponsor ID
- maca / CAAE 43373915.3.0000.5479
- Conditions
- Sexual Dysfunction, Physiological
- Keywords
- Sexual Dysfunction, Postmenopausal women, Sexual desire
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Dec 2015 (estimated)
- 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.
Objective: To study the effects of Lepidium Meyenii in sexual function of postmenopausal women.
Method: It will be held a clinical, prospective, randomized, double-blind, placebo-controlled study with 144 postmenopausal women with sexual dysfunction, treated at Menopause Clinic at the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai University. All women sign the Consent Form Term. The study will be conducted in accordance with the protocol and principles of the Declaration Helsinki (Version 1996), according to International Conference on Harmonization and Tripartite Guidelines for good clinical practice and regulatory requirements. The protocol was approved by the Ethics Committee of the Faculty of Medical Sciences of Santa Casa de São Paulo.
Hypothesis: It is expected to be an improvement of sexual function in postmenopausal women.
Detailed description
It will be a prospective, randomized, double-blind, placebo-controlled study with 144 postmenopausal women with sexual dysfunction, met in Menopause Clinic at the Faculty of Medical Sciences of Santa Casa de São Paulo and in the Vale do Sapucai University. All women signed the Informed Consent. The study will be conducted in accordance with the protocol and principles set out in Declaration of Helsinki (1996 version), according to International Conference on Harmonization and Tripartite Guidelines for good practice clinics and applicable regulatory requirements.
The protocol was submitted and approved by the Ethics Committee, Faculty of Medical Sciences Committee Santa Casa de São Paulo. The diagnosis of sexual dysfunction will be done by a sexologist physician experienced and trained in the diagnosis of female sexual disorders through a structured clinical interview, a list of sexual symptoms. It will be oriented to avoid further consumption of diet or another type of herbal medicine during the study. After the interview, signing the Informed Consent and they will be informed about the randomization. Interview with sexological questionnaires will be applied used in Sexology Clinic, Faculty of Medical Sciences of Santa Casa de São Paulo and Vale do Sapucai University, with the purpose of obtaining data sociodemographic. The Female Sexual function Index (FSFI) and the Female Intervention Efficacy Index questionnaire (FIEI). When necessary, the Beck Depression Inventory II (Cunha 2001) will be used to ward off depression, which will be applied by enabled professional. The application will be individually and by the same researcher. The results will be analyzed and interpreted in the light of the theoretical framework of socio-historical psychology, this theory of knowledge, is associated with the understanding of the culture of the structure, social organization and the rescue human subjectivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Behavioral: The Female Sexual Function Index (FSFI), Behavioral: The Female Intervention Efficacy Index (FIEI), Behavioral: The Beck Depression Inventory II, Drug: PlaceboThe effects of Placebo on sexual function, desire and depression in postmenopausal women. The Female Sexual Function Index (FSFI) and the Female Intervention Efficacy Index Questionnaire (FIEI). The Beck Depression Inventory II will be used to ward off depression |
| Maca (Lepidium Meyenii Walp) Group | Experimental | Behavioral: The Female Sexual Function Index (FSFI), Behavioral: The Female Intervention Efficacy Index (FIEI), Behavioral: The Beck Depression Inventory II, Drug: Lepidium Meyenii WalpThe effects of Lepidium Meyenii Walp on sexual function, desire and depression in postmenopausal women. The Female Sexual Function Index (FSFI) and the Female Intervention Efficacy Index Questionnaire (FIEI). The Beck Depression Inventory II will be used to ward off depression |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The postmenopausal women with full autonomy, with one year or more of amenorrhea and follicle stimulating hormone (FSH) > 30 milli-International unit/mL
- Women who are not regularly practicing sexual activity will be included because the desire domain is subject to the same evaluation in this situation
- Estrogen and progesterone were permitted if the dose had been stable for six months prior to screening
Key exclusion criteria (17 listed)
- Cardiac, renal and hepatic diseases
- Diabetes mellitus
- Cognitive disorders
- Hormone-dependent tumor
- History of psychiatric illness current and/or past, regular use of two or more doses of alcohol by day (dose = 12 grams of pure alcohol, which corresponds to 330 mL of beer, 100 mL wine, 30 mL of distilled World Health Organization standard dose) leading to impairment or clinically significant distress (DSM-5)
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 |
|---|---|---|
| The Female Sexual Function Index (FSFI)The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function | Behavioural | Maca (Lepidium Meyenii Walp) Group, Placebo Group |
| The Female Intervention Efficacy Index (FIEI)The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function | Behavioural | Maca (Lepidium Meyenii Walp) Group, Placebo Group |
| The Beck Depression Inventory IIThe Beck Depression Inventory II will be used to evaluate or ward off depression | Behavioural | Maca (Lepidium Meyenii Walp) Group, Placebo Group |
| Lepidium Meyenii WalpAlso: MacaThey will receive a capsule of Lepidium Meyenii Walp twice a day for 120 days | Drug | Maca (Lepidium Meyenii Walp) Group |
| PlaceboThey will receive a capsule of Placebo twice a day for 120 days | Drug | Placebo Group |
Primary outcome
FSFI Questionnaire to evaluate the sexual function
Time frame: 120 days
To study the effects of Lepidium meyenii and placebo on sexual function in postmenopausal women
1 secondary outcome
FIEI Questionnaire to evaluate the sexual desire
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Results publication: PubMed 14583104Dailey RK, Neale AV, Northrup J, West P, Schwartz KL. Herbal product use and menopause symptom relief in primary care patients: a MetroNet study. J Womens Health (Larchmt). 2003 Sep;12(7):633-41. doi: 10.1089/154099903322404285.
- Results publication: PubMed 16181020Geller SE, Studee L. Botanical and dietary supplements for menopausal symptoms: what works, what does not. J Womens Health (Larchmt). 2005 Sep;14(7):634-49. doi: 10.1089/jwh.2005.14.634.
- Results publication: PubMed 12435217Kronenberg F, Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002 Nov 19;137(10):805-13. doi: 10.7326/0003-4819-137-10-200211190-00009.
- Results publication: PubMed 17202872van der Sluijs CP, Bensoussan A, Liyanage L, Shah S. Women's health during mid-life survey: the use of complementary and alternative medicine by symptomatic women transitioning through menopause in Sydney. Menopause. 2007 May-Jun;14(3 Pt 1):397-403. doi: 10.1097/01.gme.0000236937.36078.f4.
- Results publication: PubMed 14962874Minelli C, Abrams KR, Sutton AJ, Cooper NJ. Benefits and harms associated with hormone replacement therapy: clinical decision analysis. BMJ. 2004 Feb 14;328(7436):371. doi: 10.1136/bmj.328.7436.371.
- Results publication: PubMed 16414334Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. doi: 10.1016/j.amjmed.2005.09.044.
- Results publication: PubMed 15763375Chung F, Rubio J, Gonzales C, Gasco M, Gonzales GF. Dose-response effects of Lepidium meyenii (Maca) aqueous extract on testicular function and weight of different organs in adult rats. J Ethnopharmacol. 2005 Apr 8;98(1-2):143-7. doi: 10.1016/j.jep.2005.01.028.
- Results publication: PubMed 23674952Meissner HO, Kapczynski W, Mscisz A, Lutomski J. Use of gelatinized maca (lepidium peruvianum) in early postmenopausal women. Int J Biomed Sci. 2005 Jun;1(1):33-45.
- Results publication: PubMed 11753476Gonzales GF, Cordova A, Gonzales C, Chung A, Vega K, Villena A. Lepidium meyenii (Maca) improved semen parameters in adult men. Asian J Androl. 2001 Dec;3(4):301-3.
- Results publication: PubMed 11561196Gonzales GF, Ruiz A, Gonzales C, Villegas L, Cordova A. Effect of Lepidium meyenii (maca) roots on spermatogenesis of male rats. Asian J Androl. 2001 Sep;3(3):231-3.
- Results publication: PubMed 12472620Gonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez C, Castillo S. Effect of Lepidium meyenii (MACA) on sexual desire and its absent relationship with serum testosterone levels in adult healthy men. Andrologia. 2002 Dec;34(6):367-72. doi: 10.1046/j.1439-0272.2002.00519.x.
- Results publication: PubMed 12525260Gonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez C. Effect of Lepidium meyenii (Maca), a root with aphrodisiac and fertility-enhancing properties, on serum reproductive hormone levels in adult healthy men. J Endocrinol. 2003 Jan;176(1):163-8. doi: 10.1677/joe.0.1760163.
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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.
Fabiola SM Campos, MD study director
Universidade do Vale do Sapucai
Sonia Maria R Rosa Lima, PhD principal investigator
Santa Casa of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The Female Sexual Function Index (FSFI), The Female Intervention Efficacy Index (FIEI) and The Beck Depression Inventory II in people with Sexual Dysfunction, Physiological, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 3 inclusion and 17 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 21 Jun 2016. 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 Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 BENEDITO FABIANO D REIS, PhD (553534730942, benefabiano@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSFI Questionnaire to evaluate the sexual function (time frame: 120 days). 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 NCT02624648, which also lists 26 linked publications.
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 21 Jun 2016.