Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Lepidium Meyenii Walp (Peruvian Maca) on Sexual Function in Postmenopausal

Conditions
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Sexual Dysfunction, Physiological

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>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)<br>* The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function<br>Behavioral: The Female Intervention Efficacy Index (FIEI)<br>* The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function<br>Behavioral: The Beck Depression Inventory II<br>* The Beck Depression Inventory II will be used to evaluate or ward off depression<br>Drug: Placebo<br>* They will receive a capsule of Placebo twice a day for 120 days<br>|
| Experimental: Maca (Lepidium Meyenii Walp) Group<br>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)<br>* The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function<br>Behavioral: The Female Intervention Efficacy Index (FIEI)<br>* The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function<br>Behavioral: The Beck Depression Inventory II<br>* The Beck Depression Inventory II will be used to evaluate or ward off depression<br>Drug: Lepidium Meyenii Walp<br>* They will receive a capsule of Lepidium Meyenii Walp twice a day for 120 days<br>* Other names: Maca;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSFI Questionnaire to evaluate the sexual function | 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 | To study the effects of Lepidium meyenii and placebo on sexual desire in postmenopausal women | 120 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Dysfunction, Postmenopausal women, Sexual desire