Clinical trial NCT04188600: Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels
Official title: 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: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Female Sexual Interest/Arousal Disorder
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
First posted: 2019-12-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The selected patients will be randomly distributed in one of the two arms (Libicare® / active-control), in a 2:1 ratio according to a randomization list. The kits containing the study treatment (Libicare®) and the active-control will be numbered with a randomization code according to this unique list and will be distributed to the consultations.

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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of sexual desire and arousal
timeFrame: 12 weeks
Secondary outcomes:
measure: The evolution of the composite score from sexual desire and arousal
timeFrame: at 6 and 24 weeks
measure: The evolution of the FSFI questionnaire total score
timeFrame: at 6, 12 and 24 weeks
measure: The evolution of other each sexual FSFI domain score
timeFrame: at 6, 12 and 24 weeks
measure: To evaluate the hormonal levels (free testosterone and SHBG)
timeFrame: at 6, 12 and 24 weeks
measure: The evolution of the vitality status obtained using the Subjective Vitality Scale questionnaire
timeFrame: at 12 and 24 weeks
measure: The improvement in the Quality of life of women by EQ-5D-5L questionnaire
timeFrame: at 12 and 24 weeks
measure: Clinical satisfaction of the women with the treatment, using a Likert-type scale
timeFrame: at 6, 12 and 24 weeks
measure: The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL©
timeFrame: at 6, 12 and 24 weeks
measure: The evaluation of the degree of therapeutic compliance
timeFrame: at 6, 12 and 24 weeks
measure: Adverse events and adverse drug reactions
timeFrame: at 6, 12 and 24 weeks.
measure: Weight, height and BMI
timeFrame: at baseline, 6, 12 and 24 weeks
Other outcomes:
Locations:
city: Castelldefels
country: Spain
facility: Procare Health Iberia
state: Barcelona
Study officials:
affiliation: Procare health Iberia
name: Josep Combalia, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.