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

Primary Purpose

Sexual Dysfunction, Physiological

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
The Female Sexual Function Index (FSFI)
The Female Intervention Efficacy Index (FIEI)
The Beck Depression Inventory II
Lepidium Meyenii Walp
Placebo
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction, Physiological focused on measuring Sexual Dysfunction, Postmenopausal women, Sexual desire

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Vale Do Sapucai University (Univas)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Maca (Lepidium Meyenii Walp) Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

FSFI Questionnaire to evaluate the sexual function
To study the effects of Lepidium meyenii and placebo on sexual function in postmenopausal women

Secondary Outcome Measures

FIEI Questionnaire to evaluate the sexual desire
To study the effects of Lepidium meyenii and placebo on sexual desire in postmenopausal women

Full Information

First Posted
November 30, 2015
Last Updated
June 19, 2016
Sponsor
Universidade do Vale do Sapucai
Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02624648
Brief Title
Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women
Acronym
maca
Official Title
Effects of Lepidium Meyenii Walp (Peruvian Maca) on Sexual Function in Postmenopausal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai
Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological
Keywords
Sexual Dysfunction, Postmenopausal women, Sexual desire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Maca (Lepidium Meyenii Walp) Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
The Female Sexual Function Index (FSFI)
Intervention Description
The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function
Intervention Type
Behavioral
Intervention Name(s)
The Female Intervention Efficacy Index (FIEI)
Intervention Description
The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function
Intervention Type
Behavioral
Intervention Name(s)
The Beck Depression Inventory II
Intervention Description
The Beck Depression Inventory II will be used to evaluate or ward off depression
Intervention Type
Drug
Intervention Name(s)
Lepidium Meyenii Walp
Other Intervention Name(s)
Maca
Intervention Description
They will receive a capsule of Lepidium Meyenii Walp twice a day for 120 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
They will receive a capsule of Placebo twice a day for 120 days
Primary Outcome Measure Information:
Title
FSFI Questionnaire to evaluate the sexual function
Description
To study the effects of Lepidium meyenii and placebo on sexual function in postmenopausal women
Time Frame
120 days
Secondary Outcome Measure Information:
Title
FIEI Questionnaire to evaluate the sexual desire
Description
To study the effects of Lepidium meyenii and placebo on sexual desire in postmenopausal women
Time Frame
120 days
Other Pre-specified Outcome Measures:
Title
The Beck Depression Inventory II to evaluate depression
Description
It will be used to evaluate or ward off depression
Time Frame
120 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BENEDITO FABIANO D REIS, PhD
Phone
553534730942
Email
benefabiano@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo Maximiliano D Silva, MD
Phone
5511994192039
Email
gumaxy@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabiola SM Campos, MD
Organizational Affiliation
Universidade do Vale do Sapucai
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sonia Maria R Rosa Lima, PhD
Organizational Affiliation
Santa Casa of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vale Do Sapucai University (Univas)
City
Pouso Alegre
State/Province
MG
ZIP/Postal Code
37550-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BENEDITO F REIS, PROF
Phone
553599844648
Email
benefabiano@uol.com.br
First Name & Middle Initial & Last Name & Degree
SONIA MARIA R ROSA LIMA, PROF
Phone
5511971519229
Email
lima@silber.com.br

12. IPD Sharing Statement

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Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women

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