NCT02624648

Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Universidade do Vale do Sapucai · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sexual Dysfunction, Physiological

Interventions

Type	Name	Description
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
DRUG	Placebo	They will receive a capsule of Placebo twice a day for 120 days

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-12-08
• Last updated: 2016-06-21

Locations

1 site across 1 country: Brazil