Sexual Dysfunction, Physiological Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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