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

Female Sexual Arousal Disorder Clinical Trial

Official title:

Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03820453
• Other study ID #: GYN-GFL-01-2018
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: August 29, 2019

Study information

• Verified date: January 2019
• Source: Kern Pharma, S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Sexual Arousal Disorder
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Dietary Supplement:
• Tribulus Terrestris
The experimental arm will receive a dietary supplement to increase the libido and sexual function

Other:
• Placebo treatment
The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics

Locations

Country	Name	City	State
Spain	CAP Manso	Barcelona
Spain	Fundació Puigvert	Barcelona
Spain	Hospital Clínic, Barcelona	Barcelona
Spain	Sexology Institute	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Kern Pharma, S.L.	Analysis and Research Network, S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Variations in testosterone levels (total, bioavailable, and free)	Testosterone levels (total, bioavailable and free) in blood	Change from baseline to 3 months visit
Secondary	Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.	Score on the Cervantes Scale on quality of life.; The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.	Change from baseline, to 3 months and optional visit at 6 months
Secondary	Number of adverse events	Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product	Thought the study, an average of 10 months.
Secondary	Compliance with treatment - Measured with the Morisky-Green scale	The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1.; Possible result values for the scale goes from 0 to 4 with 4 being a better outcome than 0.	3 months
Secondary	Compliance with treatment - Recount of refounded product by patient.	Recount of product returned at the end of study	3 months
Secondary	Compliance with treatment -Therapeutic adherence	Data will be collected by the investigator at participants visit with a unique question about percentage of intake. It will be considered a good compliance if 80% of the medication has been taken.	3 months