Effects of Lepidium Meyenii Walp on Sexual Function in Postmenopausal Women
maca
1 other identifier
interventional
144
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 21, 2016
June 1, 2016
1 year
November 30, 2015
June 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FSFI Questionnaire to evaluate the sexual function
To study the effects of Lepidium meyenii and placebo on sexual function in postmenopausal women
120 days
Secondary Outcomes (1)
FIEI Questionnaire to evaluate the sexual desire
120 days
Other Outcomes (1)
The Beck Depression Inventory II to evaluate depression
120 days
Study Arms (2)
Placebo Group
PLACEBO COMPARATORThe effects of Placebo on sexual function, desire and depression in postmenopausal women. The Female Sexual Function Index (FSFI) and the Female Intervention Efficacy Index Questionnaire (FIEI). The Beck Depression Inventory II will be used to ward off depression
Maca (Lepidium Meyenii Walp) Group
EXPERIMENTALThe effects of Lepidium Meyenii Walp on sexual function, desire and depression in postmenopausal women. The Female Sexual Function Index (FSFI) and the Female Intervention Efficacy Index Questionnaire (FIEI). The Beck Depression Inventory II will be used to ward off depression
Interventions
The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function
The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function
The Beck Depression Inventory II will be used to evaluate or ward off depression
They will receive a capsule of Lepidium Meyenii Walp twice a day for 120 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vale Do Sapucai University (Univas)
Pouso Alegre, Minas Gerais, 37550-000, Brazil
Related Publications (26)
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. doi: 10.1089/154099903322404285.
PMID: 14583104RESULTGeller 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. doi: 10.1089/jwh.2005.14.634.
PMID: 16181020RESULTKronenberg 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. doi: 10.7326/0003-4819-137-10-200211190-00009.
PMID: 12435217RESULTvan 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. doi: 10.1097/01.gme.0000236937.36078.f4.
PMID: 17202872RESULTMinelli 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. doi: 10.1136/bmj.328.7436.371.
PMID: 14962874RESULTLow Dog T. Menopause: a review of botanical dietary supplements. Am J Med. 2005 Dec 19;118 Suppl 12B:98-108. doi: 10.1016/j.amjmed.2005.09.044.
PMID: 16414334RESULTChung 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. doi: 10.1016/j.jep.2005.01.028.
PMID: 15763375RESULTMeissner 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.
PMID: 23674952RESULTGonzales 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.
PMID: 11753476RESULTGonzales 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.
PMID: 11561196RESULTGonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez 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. doi: 10.1046/j.1439-0272.2002.00519.x.
PMID: 12472620RESULTGonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez 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. doi: 10.1677/joe.0.1760163.
PMID: 12525260RESULTGonzales GF, Gasco M, Cordova 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. doi: 10.1677/joe.0.1800087.
PMID: 14709147RESULTGonzales GF, Miranda S, Nieto J, Fernandez 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. doi: 10.1186/1477-7827-3-5.
PMID: 15661081RESULTOshima 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. doi: 10.1292/jvms.65.1145.
PMID: 14600359RESULTZheng 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. doi: 10.1016/s0090-4295(99)00549-x.
PMID: 10736519RESULTCicero 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. doi: 10.1016/s0378-8741(01)00195-7.
PMID: 11297856RESULTRuiz-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. doi: 10.1186/1477-7827-3-16.
PMID: 15869705RESULTValentova K, Buckiova D, Kren V, Peknicova J, Ulrichova J, Simanek V. The in vitro biological activity of Lepidium meyenii extracts. Cell Biol Toxicol. 2006 Mar;22(2):91-9. doi: 10.1007/s10565-006-0033-0. Epub 2006 Mar 9.
PMID: 16528448RESULTBogani 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. doi: 10.1016/j.jep.2005.09.028. Epub 2005 Oct 18.
PMID: 16239088RESULTFreeman 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. doi: 10.1001/archpsyc.61.1.62.
PMID: 14706945RESULTRubio J, Caldas M, Davila 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. doi: 10.1186/1472-6882-6-23.
PMID: 16796734RESULTBosworth 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. doi: 10.1097/00006842-200107000-00013.
PMID: 11485114RESULTDennerstein 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.
PMID: 15287158RESULTGonzales GF, Gonzales C, Gonzales-Castaneda 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.
PMID: 20090350RESULTBerman 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. doi: 10.1080/713846821.
PMID: 11554203RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fabiola SM Campos, MD
Universidade do Vale do Sapucai
- PRINCIPAL INVESTIGATOR
Sonia Maria R Rosa Lima, PhD
Santa Casa of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 30, 2015
First Posted
December 8, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
June 21, 2016
Record last verified: 2016-06