Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women

Sexual Dysfunction, Physiological Clinical Trial

— maca  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02624648
• Other study ID #: CAAE 43373915.3.0000.5479
• Status: Recruiting
• Phase: Phase 1
• First received: November 30, 2015
• Last updated: June 19, 2016
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Universidade do Vale do Sapucai
• Contact: BENEDITO FABIANO D REIS, PhD
• Phone: 553534730942
• Email: benefabiano[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological

Intervention

Behavioral:
• The Female Sexual Function Index (FSFI)
The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function
• The Female Intervention Efficacy Index (FIEI)
The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function
• 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
• Placebo
They will receive a capsule of Placebo twice a day for 120 days

Locations

Country	Name	City	State
Brazil	Vale Do Sapucai University (Univas)	Pouso Alegre	MG

Sponsors (2)

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

Country where clinical trial is conducted

Brazil, 

References & Publications (26)

Berman LA, Berman JR, Werbin T, Chabra S, Goldstein I. The use of the Female Intervention Efficacy Index (FIEI) as an immediate outcome measure of medical intervention to treat female sexual dysfunction. J Sex Marital Ther. 2001 Oct-Dec;27(5):427-33. — View Citation

Bogani P, Simonini F, Iriti M, Rossoni M, Faoro F, Poletti A, Visioli F. Lepidium meyenii (Maca) does not exert direct androgenic activities. J Ethnopharmacol. 2006 Apr 6;104(3):415-7. Epub 2005 Oct 18. — View Citation

Bosworth HB, Bastian LA, Kuchibhatla MN, Steffens DC, McBride CM, Skinner CS, Rimer BK, Siegler IC. Depressive symptoms, menopausal status, and climacteric symptoms in women at midlife. Psychosom Med. 2001 Jul-Aug;63(4):603-8. — View Citation

Chung F, Rubio J, Gonzales C, Gasco M, Gonzales GF. Dose-response effects of Lepidium meyenii (Maca) aqueous extract on testicular function and weight of different organs in adult rats. J Ethnopharmacol. 2005 Apr 8;98(1-2):143-7. — View Citation

Cicero AF, Bandieri E, Arletti R. Lepidium meyenii Walp. improves sexual behaviour in male rats independently from its action on spontaneous locomotor activity. J Ethnopharmacol. 2001 May;75(2-3):225-9. — View Citation

Dailey RK, Neale AV, Northrup J, West P, Schwartz KL. Herbal product use and menopause symptom relief in primary care patients: a MetroNet study. J Womens Health (Larchmt). 2003 Sep;12(7):633-41. — View Citation

Dennerstein L, Alexander JL, Kotz K. The menopause and sexual functioning: a review of the population-based studies. Annu Rev Sex Res. 2003;14:64-82. Review. — View Citation

Freeman EW, Sammel MD, Liu L, Gracia CR, Nelson DB, Hollander L. Hormones and menopausal status as predictors of depression in women in transition to menopause. Arch Gen Psychiatry. 2004 Jan;61(1):62-70. — View Citation

Geller SE, Studee L. Botanical and dietary supplements for menopausal symptoms: what works, what does not. J Womens Health (Larchmt). 2005 Sep;14(7):634-49. Review. — View Citation

Gonzales GF, Cordova A, Gonzales C, Chung A, Vega K, Villena A. Lepidium meyenii (Maca) improved semen parameters in adult men. Asian J Androl. 2001 Dec;3(4):301-3. — View Citation

Gonzales GF, Córdova A, Vega K, Chung A, Villena A, Góñez C, Castillo S. Effect of Lepidium meyenii (MACA) on sexual desire and its absent relationship with serum testosterone levels in adult healthy men. Andrologia. 2002 Dec;34(6):367-72. — View Citation

Gonzales GF, Córdova A, Vega K, Chung A, Villena A, Góñez C. Effect of Lepidium meyenii (Maca), a root with aphrodisiac and fertility-enhancing properties, on serum reproductive hormone levels in adult healthy men. J Endocrinol. 2003 Jan;176(1):163-8. — View Citation

Gonzales GF, Gasco M, Córdova A, Chung A, Rubio J, Villegas L. Effect of Lepidium meyenii (Maca) on spermatogenesis in male rats acutely exposed to high altitude (4340 m). J Endocrinol. 2004 Jan;180(1):87-95. — View Citation

Gonzales GF, Gonzales C, Gonzales-Castañeda C. Lepidium meyenii (Maca): a plant from the highlands of Peru--from tradition to science. Forsch Komplementmed. 2009 Dec;16(6):373-80. doi: 10.1159/000264618. Epub 2009 Dec 16. Review. — View Citation

Gonzales GF, Miranda S, Nieto J, Fernández G, Yucra S, Rubio J, Yi P, Gasco M. Red maca (Lepidium meyenii) reduced prostate size in rats. Reprod Biol Endocrinol. 2005 Jan 20;3:5. — View Citation

Gonzales GF, Ruiz A, Gonzales C, Villegas L, Cordova A. Effect of Lepidium meyenii (maca) roots on spermatogenesis of male rats. Asian J Androl. 2001 Sep;3(3):231-3. — View Citation

Kronenberg F, Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002 Nov 19;137(10):805-13. Review. — View Citation

Low Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. Review. — View Citation

Meissner HO, Kapczynski W, Mscisz A, Lutomski J. Use of gelatinized maca (lepidium peruvianum) in early postmenopausal women. Int J Biomed Sci. 2005 Jun;1(1):33-45. — View Citation

Minelli C, Abrams KR, Sutton AJ, Cooper NJ. Benefits and harms associated with hormone replacement therapy: clinical decision analysis. BMJ. 2004 Feb 14;328(7436):371. — View Citation

Oshima M, Gu Y, Tsukada S. Effects of Lepidium meyenii Walp and Jatropha macrantha on blood levels of estradiol-17 beta, progesterone, testosterone and the rate of embryo implantation in mice. J Vet Med Sci. 2003 Oct;65(10):1145-6. — View Citation

Rubio J, Caldas M, Dávila S, Gasco M, Gonzales GF. Effect of three different cultivars of Lepidium meyenii (Maca) on learning and depression in ovariectomized mice. BMC Complement Altern Med. 2006 Jun 23;6:23. — View Citation

Ruiz-Luna AC, Salazar S, Aspajo NJ, Rubio J, Gasco M, Gonzales GF. Lepidium meyenii (Maca) increases litter size in normal adult female mice. Reprod Biol Endocrinol. 2005 May 3;3:16. — View Citation

Valentová K, Buckiová D, Kren V, Peknicová J, Ulrichová J, Simánek V. The in vitro biological activity of Lepidium meyenii extracts. Cell Biol Toxicol. 2006 Mar;22(2):91-9. Epub 2006 Mar 9. — View Citation

van der Sluijs CP, Bensoussan A, Liyanage L, Shah S. Women's health during mid-life survey: the use of complementary and alternative medicine by symptomatic women transitioning through menopause in Sydney. Menopause. 2007 May-Jun;14(3 Pt 1):397-403. — View Citation

Zheng BL, He K, Kim CH, Rogers L, Shao Y, Huang ZY, Lu Y, Yan SJ, Qien LC, Zheng QY. Effect of a lipidic extract from lepidium meyenii on sexual behavior in mice and rats. Urology. 2000 Apr;55(4):598-602. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Beck Depression Inventory II to evaluate depression	It will be used to evaluate or ward off depression	120 days	Yes
Primary	FSFI Questionnaire to evaluate the sexual function	To study the effects of Lepidium meyenii and placebo on sexual function in postmenopausal women	120 days	Yes
Secondary	FIEI Questionnaire to evaluate the sexual desire	To study the effects of Lepidium meyenii and placebo on sexual desire in postmenopausal women	120 days	Yes