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

June 19, 2016 updated by: Benedito Fabiano dos Reis, Universidade do Vale do Sapucai

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • MG
      • Pouso Alegre, MG, Brazil, 37550-000
        • Recruiting
        • Vale Do Sapucai University (Univas)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • Maca

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
120 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Beck Depression Inventory II to evaluate depression
Time Frame: 120 days
It will be used to evaluate or ward off depression
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Vale do Sapucai

Collaborators

Irmandade da Santa Casa de Misericordia de Sao Paulo

Investigators

  • Study Director: Fabiola SM Campos, MD, Universidade do Vale do Sapucai
  • Principal Investigator: Sonia Maria R Rosa Lima, PhD, Santa Casa of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (ESTIMATE)

December 8, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 19, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 43373915.3.0000.5479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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