Clinical trial NCT02624648: Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women
Official title: Effects of Lepidium Meyenii Walp (Peruvian Maca) on Sexual Function in Postmenopausal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sexual Dysfunction, Physiological
Keywords: Sexual Dysfunction
Postmenopausal women
Sexual desire
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
Collaborators: name: Irmandade da Santa Casa de Misericordia de Sao Paulo
First posted: 2015-12-08
Enrollment: 144
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: FSFI Questionnaire to evaluate the sexual function
timeFrame: 120 days
Secondary outcomes:
measure: FIEI Questionnaire to evaluate the sexual desire
timeFrame: 120 days
Other outcomes:
measure: The Beck Depression Inventory II to evaluate depression
timeFrame: 120 days
Locations:
city: Pouso Alegre
country: Brazil
facility: Vale Do Sapucai University (Univas)
state: MG
Study officials:
affiliation: Universidade do Vale do Sapucai
name: Fabiola SM Campos, MD
role: STUDY_DIRECTOR
affiliation: Santa Casa of São Paulo
name: Sonia Maria R Rosa Lima, PhD
role: PRINCIPAL_INVESTIGATOR
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