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

NCT04188600 | Withdrawn

• 1 other identifier: VITAL STUDY
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Interest/Arousal Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (11)

• The evolution of the composite score from sexual desire and arousal

  at 6 and 24 weeks

• The evolution of the FSFI questionnaire total score

  at 6, 12 and 24 weeks

• The evolution of other each sexual FSFI domain score

  at 6, 12 and 24 weeks

• To evaluate the hormonal levels (free testosterone and SHBG)

  at 6, 12 and 24 weeks

• The evolution of the vitality status obtained using the Subjective Vitality Scale questionnaire

  at 12 and 24 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

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).

Dietary Supplement: Libicare

active control group

ACTIVE COMPARATOR

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)

Dietary Supplement: Libicare; Dietary Supplement: active control

Interventions

Libicare DIETARY_SUPPLEMENT

The main ingredients of Libicare® are: * Trigonella Foenum-graecum (Trigonella) * Tribulus Terrestris (Tribulus) * Turnera Diffusa (Damiana)

active control group; treatment group

active control DIETARY_SUPPLEMENT

Selenium and vitamins B complex

active control group

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Peri or postmenopausal women older 45 years with low sexual desire and arousal
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged between 40 and 60 years old.
• Healthy peri or postmenopausal women.
• Body Mass Index (BMI) between 18,5-29,9.
• Female with low sexual desire and low arousal with a score ≤26.55 on the questionnaire Female Sexual Function Index (FSFI) .
• Patients who signed the Informed Consent Form.

You may not qualify if:

• Female with uncontrolled thyroid function.
• Female with severe genital pain (vaginism, stopping intercourse because of severe pain).
• Female diagnosed with primary female orgasmic disorder.
• No coital intercourse a month.
• Lack of steady sexual partner.
• Suffering from any serious medical condition (any disease which may force the participant to use drug during the study).
• Suffering from major depression disorder or other psychiatric disorders.
• Women on anticoagulant treatment.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead

Study Sites (1)

Procare Health Iberia

Castelldefels, Barcelona, 08860, Spain

Location

Related Publications (3)

• 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.

  PMID: 25914334 RESULT

• 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.

  PMID: 24773615 RESULT

• 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.

  PMID: 18948180 RESULT

Study Officials

• Josep Combalia, MD

  Procare health Iberia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The analysis of the results will be blind for the investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 6, 2019
• Study Start: November 14, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)