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

Procare Health

Status: Withdrawn

Conditions: Female Sexual Interest/Arousal Disorder

Treatments: Dietary Supplement: Libicare; Dietary Supplement: active control

Study type: Interventional

Funder types: Industry

Identifiers

NCT04188600

VITAL STUDY

Details and patient eligibility

About

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 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.

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

treatment group

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Libicare

active control group

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: active control

Dietary Supplement: Libicare