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Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women

NCT02624648 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2016-06-21

No results posted yet for this study

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.

Conditions

  • Sexual Dysfunction, Physiological

Interventions

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

Sponsors & Collaborators

  • Irmandade da Santa Casa de Misericordia de Sao Paulo

    collaborator OTHER

  • Universidade do Vale do Sapucai

    lead OTHER

Principal Investigators

  • Fabiola SM Campos, MD · Universidade do Vale do Sapucai

  • Sonia Maria R Rosa Lima, PhD · Santa Casa of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624648 on ClinicalTrials.gov