Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade do Vale do Sapucai
• Collaborator: Irmandade da Santa Casa de Misericordia de Sao Paulo

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