Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women

This study has been completed.

Sponsor:

Collaborator:

Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by (Responsible Party):

Sonia Maria Rolim Rosa Lima, Faculdade de Ciências Médicas da Santa Casa de São Paulo

ClinicalTrials.gov Identifier:

NCT01407445

First received: August 1, 2011

Last updated: November 9, 2015

Last verified: November 2015

History of Changes

Purpose

Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.

Condition	Intervention	Phase
Sexual Functions and Problems in the Adult	Drug: Placebo Drug: Tribulus terrestris	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women

Further study details as provided by Sonia Maria Rolim Rosa Lima, Faculdade de Ciências Médicas da Santa Casa de São Paulo:

Primary Outcome Measures:

Sexual function in post-menopausal women [ Time Frame: 90 days ]
Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).

Secondary Outcome Measures:

Female Intervention Efficacy Index (FIEI) [ Time Frame: 3 months ]


Enrollment:	60
Study Start Date:	January 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo 1 tablet of placebo/ oral/ 3 times a day for three months	Drug: Placebo 1 tablet/ oral/ 3 times a day for 90 days Other Name: lot 168159
Active Comparator: Tribulus terrestris 1 tablet of 250mg/ oral/ 3 times a day for three months	Drug: Tribulus terrestris 1 tablet of 250mg/ oral/ 3 times a day for 90 days Other Name: lot 168059

Detailed Description:

Sexuality is an integral part of every personality, influence thoughts, feelings, actions, integrations, and therefore the physical and mental health. It is estimated that 43% of women have at least one complaint of sexual problem. Disorders of desire and arousal are among the most common problems found in gynecologic practice. Medicinal plants have been used for therapeutic purposes for thousands of years, and aphrodisiac properties described in several plants. Tribulus terrestris is a plant indigenous to India, recommended in the treatment of infertility, low libido and impotence, and its main active ingredient protodioscin (PTN).

Eligibility


Ages Eligible for Study:	40 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women past menopause, with full autonomy, at least one year of amenorrhea and FSH> 30 mIU / mL.
Sexually active
Partner is stable and without sexual difficulties
Carrier sexual abuse (desire, arousal, orgasm and dyspareunia)

Exclusion Criteria:

Women on hormone therapy within the preceding 12 months
Women without sexual activity
With diabetes mellitus
Patients with cognitive impairment
Patients with hormone-dependent tumor
History of psychiatric illness
Patients with liver disease
Patients with kidney disease
Users of drugs with proven to decrease sexual desire
Cardivascular disease, renal disease.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407445

Locations


Brazil
Santa Casa of Sao Paulo Medical School
Sao Paulo, Brazil

Sponsors and Collaborators

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators


Principal Investigator:	Sonia lima, PhD	Faculdade de Ciências Médicas da Santa Casa de São Paulo

More Information


Responsible Party:	Sonia Maria Rolim Rosa Lima, Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:	NCT01407445 History of Changes
Other Study ID Numbers:	Fcmscsp-tribulus terrestris ( Other Identifier: CEP-008/2009 )
Study First Received:	August 1, 2011
Last Updated:	November 9, 2015

Keywords provided by Sonia Maria Rolim Rosa Lima, Faculdade de Ciências Médicas da Santa Casa de São Paulo:


Menopause Sexual dysfunction Tribulus Sexuality Phytotherapeutic Drugs

ClinicalTrials.gov processed this record on June 27, 2017

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