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

NCT03820453 | Unknown

• 1 other identifier: GYN-GFL-01-2018
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Female Sexual Arousal Disorder

Outcome Measures

Primary Outcomes (1)

• Changes of Score on the Female Sexual Function Index (FSFI)

  Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido. The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome. Scale subdomains, their scoring range and factor to the total score is the following: Domain: Desire, Range \[1 - 5\] Factor: 0.6 Domain: Arousal, Range \[0 - 5\] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range \[0 (or 1) - 5 \] Factor: 0.4 Domain: Pain Range \[0-5\] Factor: 0.4

  At baseline, at 6 weeks, at 3 months and at 6 months (optional)

Secondary Outcomes (6)

• Variations in testosterone levels (total, bioavailable, and free)

  Change from baseline to 3 months visit

• Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.

  Change from baseline, to 3 months and optional visit at 6 months

• Number of adverse events

  Thought the study, an average of 10 months.

• Compliance with treatment - Measured with the Morisky-Green scale

  3 months

• Compliance with treatment - Recount of refounded product by patient.

  3 months

Study Arms (2)

Active group

EXPERIMENTAL

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.

Dietary Supplement: Tribulus Terrestris

Control group

PLACEBO COMPARATOR

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

Other: Placebo treatment

Interventions

Tribulus Terrestris DIETARY_SUPPLEMENT

The experimental arm will receive a dietary supplement to increase the libido and sexual function

Active group

Placebo treatment OTHER

The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics

Control group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kern Pharma, S.L.: lead
• Analysis and Research Network, S.L: collaborator

Study Sites (4)

CAP Manso

Barcelona, 08015, Spain

NOT YET RECRUITING

Fundació Puigvert

Barcelona, Spain

NOT YET RECRUITING

Hospital Clínic, Barcelona

Barcelona, Spain

ACTIVE NOT RECRUITING

Sexology Institute

Barcelona, Spain

RECRUITING

MeSH Terms

Interventions

Tribulus extract

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 29, 2019
• Study Start: October 29, 2018
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

ES (4)