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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The main ingredients of Libicare® are: * Trigonella Foenum-graecum (Trigonella) * Tribulus Terrestris (Tribulus) * Turnera Diffusa (Damiana)
Selenium and vitamins B complex
Procare Health Iberia
Castelldefels, Barcelona, Spain
Evolution of sexual desire and arousal
The evolution of the composite score from sexual desire and arousal obtained using FSFI (Female Sexual Function Index) questionnaire. It has 19 questions with six domains included desire, arousal, lubrication, orgasm, satisfaction and pain, and a general score in which higher scores reflected better sexual activity.
Time frame: 12 weeks
The evolution of the composite score from sexual desire and arousal
The evolution of the composite score from sexual desire and arousal obtained using FSFI (Female Sexual Function Index) questionnaire. It has 19 questions with six domains included desire, arousal, lubrication, orgasm, satisfaction and pain, and a general score in which higher scores reflected better sexual activity.
Time frame: at 6 and 24 weeks
The evolution of the FSFI questionnaire total score
The evolution of the FSFI (Female Sexual Function Index) questionnaire total score. Composite score from sexual desire and arousal domains will be calculed as the sum of desire items (2 questions) and arousal items (4 questions). Higher scores reflected better sexual activity.
Time frame: at 6, 12 and 24 weeks
The evolution of other each sexual FSFI domain score
The evolution of other each sexual FSFI domain score (Female Sexual Function Index) It contains 2 questions of desire domain and 4 questions of arousal domain. Higher scores reflected better sexual activity.
Time frame: at 6, 12 and 24 weeks
To evaluate the hormonal levels (free testosterone and SHBG)
changes in hormonals levels
Time frame: at 6, 12 and 24 weeks
The evolution of the vitality status obtained using the Subjective Vitality Scale questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The evolution of the vitality scale (an 7-point Likert Scale) contains 7 items. Higher scores reflected better vitality status.
Time frame: at 12 and 24 weeks
The improvement in the Quality of life of women by EQ-5D-5L questionnaire
The improvement in the Quality of life of women by EQ-5D-5L (European Quality of Life-5 Dimensions) questionnaire. It comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The result is in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: at 12 and 24 weeks
Clinical satisfaction of the women with the treatment, using a Likert-type scale
Clinical satisfaction of the women with the treatment, using a Likert-type scale of 7 points (from 1 = Very satisfied to 7 = Very dissatisfied)
Time frame: at 6, 12 and 24 weeks
The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL©
The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL© ((Sexual Activity Log©). It is a weekly diary that it measures frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms.
Time frame: at 6, 12 and 24 weeks
The evaluation of the degree of therapeutic compliance
The evaluation of the degree of therapeutic compliance throught Likert Scale of 5 points (from 1 = Very satisfied to 5 = Very dissatisfied) will be analysed by means of percentage.
Time frame: at 6, 12 and 24 weeks
Adverse events and adverse drug reactions
To evaluate the safety of libicare measuring the incidence and duration of adverse events and adverse drug reactions.
Time frame: at 6, 12 and 24 weeks.
Weight, height and BMI
Safety endpoint for evaluating weigh and BMI (body mass index) changes.
Time frame: at baseline, 6, 12 and 24 weeks