Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels
NCT ID: NCT04188600
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-11-14
2023-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
Patients will not know the treatment and only the researchers and team investigator assigned to the study will know the treatment assigned.
A second randomization list (ratio 1:1) will be generated for Libicare® responding patients, at 12 weeks in order to assign two sub-groups: continue Libicare® treatment or observation without Libicare® treatment.
TREATMENT
DOUBLE
Study Groups
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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).
Libicare
The main ingredients of Libicare® are:
* Trigonella Foenum-graecum (Trigonella)
* Tribulus Terrestris (Tribulus)
* Turnera Diffusa (Damiana)
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)
Libicare
The main ingredients of Libicare® are:
* Trigonella Foenum-graecum (Trigonella)
* Tribulus Terrestris (Tribulus)
* Turnera Diffusa (Damiana)
active control
Selenium and vitamins B complex
Interventions
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Libicare
The main ingredients of Libicare® are:
* Trigonella Foenum-graecum (Trigonella)
* Tribulus Terrestris (Tribulus)
* Turnera Diffusa (Damiana)
active control
Selenium and vitamins B complex
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
FEMALE
No
Sponsors
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Procare Health Iberia S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Josep Combalia, MD
Role: STUDY_DIRECTOR
Procare health Iberia
Locations
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Procare Health Iberia
Castelldefels, Barcelona, Spain
Countries
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References
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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(1):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.
Other Identifiers
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VITAL STUDY
Identifier Type: -
Identifier Source: org_study_id
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