NCT04188600

Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels

National, Multicentric, Randomized, Single-blind, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Procare Health Iberia S.L. · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control.

Detailed description

The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control. Despite current consensus in the literature that Female Sexual Dysfunction can manifest at any age in a woman´s life, researchers as Sarrel documented that during menopause, up to 40% of women are experiencing a decrease in their sexual libido. The common assumption is that the menopause contributes to a drop of the sexual desire probably as a result of low production of hormones from ovaries, at the same time will reduce the estrogen and testosterone. This reduction starts to be reduced in the thirties and continues to reduce progressively at a constant rate reaching of about 50% of their initial highest levels by the time they reach menopause. Other hormones could be involved as Sex hormone-binding globulin (SHBG) or dehydroepiandrosterone (DHEA), both are related with testosterone levels. Libicare® is a dietary supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels.

Conditions

• Female Sexual Interest/Arousal Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Libicare	The main ingredients of Libicare® are: * Trigonella Foenum-graecum (Trigonella) * Tribulus Terrestris (Tribulus) * Turnera Diffusa (Damiana)
DIETARY_SUPPLEMENT	active control	Selenium and vitamins B complex

Timeline

• Start date: 2019-11-14
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2019-12-06
• Last updated: 2024-04-04

Locations

1 site across 1 country: Spain