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Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women (maca)

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ClinicalTrials.gov Identifier: NCT02624648
Recruitment Status : Unknown
Verified June 2016 by Benedito Fabiano dos Reis, Universidade do Vale do Sapucai.
Recruitment status was:  Recruiting
First Posted : December 8, 2015
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Irmandade da Santa Casa de Misericordia de Sao Paulo
Information provided by (Responsible Party):
Benedito Fabiano dos Reis, Universidade do Vale do Sapucai

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
Sexual Dysfunction, Physiological Behavioral: The Female Sexual Function Index (FSFI) Behavioral: The Female Intervention Efficacy Index (FIEI) Behavioral: The Beck Depression Inventory II Drug: Lepidium Meyenii Walp Drug: Placebo Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Lepidium Meyenii Walp (Peruvian Maca) on Sexual Function in Postmenopausal
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Group

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

 Behavioral: The Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function

Behavioral: The Female Intervention Efficacy Index (FIEI)
The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function

Behavioral: The Beck Depression Inventory II
The Beck Depression Inventory II will be used to evaluate or ward off depression

Drug: Placebo
They will receive a capsule of Placebo twice a day for 120 days
Experimental: Maca (Lepidium Meyenii Walp) Group

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

 Behavioral: The Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function

Behavioral: The Female Intervention Efficacy Index (FIEI)
The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function

Behavioral: The Beck Depression Inventory II
The Beck Depression Inventory II will be used to evaluate or ward off depression

Drug: Lepidium Meyenii Walp
They will receive a capsule of Lepidium Meyenii Walp twice a day for 120 days
Other Name: Maca


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. FIEI Questionnaire to evaluate the sexual desire [ Time Frame: 120 days ]
    To study the effects of Lepidium meyenii and placebo on sexual desire in postmenopausal women


Other Outcome Measures:
  1. The Beck Depression Inventory II to evaluate depression [ Time Frame: 120 days ]
    It will be used to evaluate or ward off depression


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624648


Contacts
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Contact: BENEDITO FABIANO D REIS, PhD 553534730942 benefabiano@uol.com.br
Contact: Gustavo Maximiliano D Silva, MD 5511994192039 gumaxy@yahoo.com.br

Locations
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Brazil
Vale Do Sapucai University (Univas) Recruiting
Pouso Alegre, MG, Brazil, 37550-000
Contact: BENEDITO F REIS, PROF    553599844648    benefabiano@uol.com.br   
Contact: SONIA MARIA R ROSA LIMA, PROF    5511971519229    lima@silber.com.br   
Sponsors and Collaborators
Universidade do Vale do Sapucai
Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
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Study Director: Fabiola SM Campos, MD Universidade do Vale do Sapucai
Principal Investigator: Sonia Maria R Rosa Lima, PhD Santa Casa of São Paulo
More Information
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Publications of Results:

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Responsible Party: Benedito Fabiano dos Reis, MD, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT02624648    
Other Study ID Numbers: CAAE 43373915.3.0000.5479
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Keywords provided by Benedito Fabiano dos Reis, Universidade do Vale do Sapucai:
Sexual Dysfunction
Postmenopausal women
Sexual desire
Additional relevant MeSH terms:
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Sexual Dysfunction, Physiological