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

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Status and phase: Completed; Phase 4

Conditions: Sexual Functions and Problems in the Adult

Treatments: Drug: Tribulus terrestris; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01407445

terrestris (Other Identifier)

Fcmscsp-tribulus

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1 tablet of placebo/ oral/ 3 times a day for three months

Treatment:

Drug: Placebo

Tribulus terrestris

Active Comparator group

Description:

1 tablet of 250mg/ oral/ 3 times a day for three months

Treatment:

Drug: Tribulus terrestris