Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.

Kern Pharma

Status: Unknown

Conditions: Female Sexual Arousal Disorder

Treatments: Other: Placebo treatment; Dietary Supplement: Tribulus Terrestris

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03820453

GYN-GFL-01-2018

Details and patient eligibility

About

This clinical Trial will assess the effects of a dietary supplement based on Tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the FSFI scale and different variables during 3 months period. Participants will be allocated to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks and at 24 weeks optional).

Enrollment: 110 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
• Post-menopause.
• Age between 45 and 65 years.
• Sexually active.
• Agreement to participate and to sign the informed consent documents.

Exclusion criteria

• Pregnancy.
• Women who are on hormone replacement therapy or who need to start it.
• Cancer treatment or a recent history of cancer (<2 years).
• Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible)
• Fibromyalgia.
• Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.).
• Any comorbidity that may interfere with the pathology under study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Active group

Experimental group

Description:

One tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months.

Treatment:

Dietary Supplement: Tribulus Terrestris

Control group

Placebo Comparator group

Description:

One tablet per day in the morning through oral administration of Placebo. During three months.

Treatment:

Other: Placebo treatment