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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 20, 2020

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: treatment group
    • The treatment group will be treated with Libicare for three month (2 tablets/day). After the first three months (12 weeks) of treatment, the treatment group will be classified into two populations: Responding patients: this population, defined by FSFI score > 26.55, will be randomized (1:1) into 2 groups: one of them will take Libicare® for further 12 weeks (total period on treatment: 24 weeks) and the other group will remain under observation with no treatment for further 12 weeks (total period on treatment: 12 weeks). Non-responding patients: this population, defined by FSFI score ≤ 26.55, will intake Libicare® for further 12 weeks (total period on treatment: 24 weeks).
  • Active Comparator: active control group
    • The active control group will be treated with a Selenium and vitamins B complex for three month (2tablets/day). After the first three months (12 weeks) of treatment, patients of the active-control group will cross over the treatment to Libicare® for three months (12 weeks)

Clinical Trial Outcome Measures

Primary Measures

  • evolution of sexual desire and arousal
    • Time Frame: 12 weeks
    • the evolution of the composite score from sexual desire and arousal obtained using FSFI questionnaire at 12 weeks. Composite score from sexual desire and arousal domains will be calculed as the sum of desire items (2 questions) and arousal items (4 questions)

Secondary Measures

  • evolution of sexual desire and arousal
    • Time Frame: at 6 and 24 weeks
    • The evolution of the composite score from sexual desire and arousal obtained using FSFI questionnaire
  • Changes on FSFI global score
    • Time Frame: at 6, 12 and 24 weeks
    • The evolution of the FSFI questionnaire total score
  • Changes on each sexual FSFI domain score
    • Time Frame: at 6, 12 and 24 weeks
    • The evolution of other each sexual FSFI domain score
  • change in hormone levels
    • Time Frame: at 6, 12 and 24 weeks
    • The change in Testosterone levels
  • change in hormone levels
    • Time Frame: at 6, 12 and 24 weeks
    • The change in SHBG levels
  • Changes in vitality scale
    • Time Frame: at 12 and 24 weeks
    • The evolution of the vitality scale (an 7-point Likert Scale)
  • Changes in Quality of life
    • Time Frame: at 12 and 24 weeks
    • The improvement in the Quality of life of women by MENQoL questionnaire
  • treatment satisfaction
    • Time Frame: at 6, 12 and 24 weeks
    • Clinical satisfaction of the women with the treatment, using a Likert-type scale of 6 points (from 1 = Very satisfied to 7 = Very dissatisfied)
  • Imrovement of Sexual Disorder Symtoms
    • Time Frame: at 6, 12 and 24 weeks
    • The improvement of the severity of sexual disorder symptoms in women using the SIDI-F
  • therapeutic compliance
    • Time Frame: at 6, 12 and 24 weeks
    • The evaluation of the degree of therapeutic compliance throught a 5-points Likert Scale
  • SAEs and AEs
    • Time Frame: at 6, 12 and 24 weeks.
    • - Incidence and duration of adverse events and adverse drug reactions (including severity)
  • Vital sign
    • Time Frame: at baseline, 6, 12 and 24 weeks
    • evalutaion of weight changes (in Kg)
  • Vital sign
    • Time Frame: at baseline, 6, 12 and 24 weeks
    • evalutaion of BMI changes (in kg/m^2)

Participating in This Clinical Trial

Inclusion Criteria

1. Female aged between 40 and 60 years old.

2. Healthy peri or postmenopausal women.

3. Body Mass Index (BMI) between 18,5-29,9.

4. Female with low sexual desire and low arousal with a score ≤26.55 on the questionnaire Female Sexual Function Index (FSFI) .

5. Patients who signed the Informed Consent Form.

Exclusion Criteria

1. Female with uncontrolled thyroid function.

2. Female with severe genital pain (vaginism, stopping intercourse because of severe pain).

3. Female diagnosed with primary female orgasmic disorder.

4. No coital intercourse a month.

5. Lack of steady sexual partner.

6. Suffering from any serious medical condition (any disease which may force the participant to use drug during the study).

7. Suffering from major depression disorder or other psychiatric disorders.

8. Women on anticoagulant treatment.

Gender Eligibility: Female

Peri or postmenopausal women older 45 years with low sexual desire and arousal

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Procare Health Iberia S.L.
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Rao A, Steels E, Beccaria G, Inder WJ, Vitetta L. Influence of a Specialized Trigonella foenum-graecum Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study. Phytother Res. 2015 Aug;29(8):1123-30. doi: 10.1002/ptr.5355. Epub 2015 Apr 24.

Akhtari E, Raisi F, Keshavarz M, Hosseini H, Sohrabvand F, Bioos S, Kamalinejad M, Ghobadi A. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo – controlled study. Daru. 2014 Apr 28;22:40. doi: 10.1186/2008-2231-22-40.

Zhao J, Dasmahapatra AK, Khan SI, Khan IA. Anti-aromatase activity of the constituents from damiana (Turnera diffusa). J Ethnopharmacol. 2008 Dec 8;120(3):387-93. doi: 10.1016/j.jep.2008.09.016. Epub 2008 Sep 26.

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