Female Sexual Interest/Arousal DisorderVITALNCT04188600
Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels
A study testing Libicare in people with Female Sexual Interest/Arousal Disorder, run by Procare Health Iberia S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Female Sexual Interest/Arousal Disorder
- What is being tested?
- Libicare
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 14 Nov 2019to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Female Sexual Interest/Arousal Disorder
- Being tested
- Libicare, active control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LibicareDietary supplement
The main ingredients of Libicare® are:
- Trigonella Foenum-graecum (Trigonella)
- Tribulus Terrestris (Tribulus)
- Turnera Diffusa (Damiana)
active controlDietary supplement
Selenium and vitamins B complex
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Dietary Supplement: Libicare; Dietary Supplement: active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (11)
The evolution of the composite score from 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.
Measured: at 6 and 24 weeks
The evolution of the FSFI questionnaire total score
The evolution of the FSFI (Female Sexual Function Index) questionnaire total score. Composite score from sexual desire and arousal domains will be calculed as the sum of desire items (2 questions) and arousal items (4 questions). Higher scores reflected better sexual activity.
Measured: at 6, 12 and 24 weeks
The evolution of other each sexual FSFI domain score
The evolution of other each sexual FSFI domain score (Female Sexual Function Index) It contains 2 questions of desire domain and 4 questions of arousal domain. Higher scores reflected better sexual activity.
Measured: at 6, 12 and 24 weeks
To evaluate the hormonal levels (free testosterone and SHBG)
changes in hormonals levels
Measured: at 6, 12 and 24 weeks
The evolution of the vitality status obtained using the Subjective Vitality Scale questionnaire
The evolution of the vitality scale (an 7-point Likert Scale) contains 7 items. Higher scores reflected better vitality status.
Measured: at 12 and 24 weeks
The improvement in the Quality of life of women by EQ-5D-5L questionnaire
The improvement in the Quality of life of women by EQ-5D-5L (European Quality of Life-5 Dimensions) questionnaire. It comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The result is in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: at 12 and 24 weeks
Clinical satisfaction of the women with the treatment, using a Likert-type scale
Clinical satisfaction of the women with the treatment, using a Likert-type scale of 7 points (from 1 = Very satisfied to 7 = Very dissatisfied)
Measured: at 6, 12 and 24 weeks
The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL©
The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL© ((Sexual Activity Log©). It is a weekly diary that it measures frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms.
Measured: at 6, 12 and 24 weeks
The evaluation of the degree of therapeutic compliance
The evaluation of the degree of therapeutic compliance throught Likert Scale of 5 points (from 1 = Very satisfied to 5 = Very dissatisfied) will be analysed by means of percentage.
Measured: at 6, 12 and 24 weeks
Adverse events and adverse drug reactions
To evaluate the safety of libicare measuring the incidence and duration of adverse events and adverse drug reactions.
Measured: at 6, 12 and 24 weeks.
Weight, height and BMI
Safety endpoint for evaluating weigh and BMI (body mass index) changes.
Measured: at baseline, 6, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start14 Nov 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female Sexual Interest/Arousal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josep Combalia, MD, Study director, Procare health Iberia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188600
- Sponsor's protocol ID
- VITAL STUDY
- Acronym
- VITAL
- Status last verified
- Apr 2024
- First submitted
- 27 Nov 2019
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25914334Akhtari 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.
PubMed 24773615Zhao 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.
PubMed 18948180
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04188600
- Acronym / sponsor ID
- VITAL / VITAL STUDY
- Conditions
- Female Sexual Interest/Arousal Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Dietary Supplement: LibicareThe 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 control group | Active comparator | Dietary Supplement: Libicare, Dietary Supplement: active controlThe 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) |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LibicareThe main ingredients of Libicare® are: * Trigonella Foenum-graecum (Trigonella) * Tribulus Terrestris (Tribulus) * Turnera Diffusa (Damiana) | Dietary supplement | active control group, treatment group |
| active controlSelenium and vitamins B complex | Dietary supplement | active control group |
Primary outcome
Evolution of sexual desire and arousal
Time frame: 12 weeks
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.
11 secondary outcomes
The evolution of the composite score from sexual desire and arousal
Time frame: at 6 and 24 weeks
The evolution of the FSFI questionnaire total score
Time frame: at 6, 12 and 24 weeks
The evolution of other each sexual FSFI domain score
Time frame: at 6, 12 and 24 weeks
To evaluate the hormonal levels (free testosterone and SHBG)
Time frame: at 6, 12 and 24 weeks
The evolution of the vitality status obtained using the Subjective Vitality Scale questionnaire
Time frame: at 12 and 24 weeks
The improvement in the Quality of life of women by EQ-5D-5L questionnaire
Time frame: at 12 and 24 weeks
Clinical satisfaction of the women with the treatment, using a Likert-type scale
Time frame: at 6, 12 and 24 weeks
The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL©
Time frame: at 6, 12 and 24 weeks
The evaluation of the degree of therapeutic compliance
Time frame: at 6, 12 and 24 weeks
Adverse events and adverse drug reactions
Time frame: at 6, 12 and 24 weeks.
Weight, height and BMI
Time frame: at baseline, 6, 12 and 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Results publication: PubMed 25914334Rao 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.
- Results publication: PubMed 24773615Akhtari 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.
- Results publication: PubMed 18948180Zhao 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.
- Individual participant dataSharing planned: No
Related trials for Female Sexual Interest/Arousal Disorder
Not yet recruiting
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
Menopause, Sexual Dysfunction
Recruiting
Cognitive-Behavioural Couple Therapy for Sexual Interest/Arousal Disorder
Sexual Interest/Arousal Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Combalia, MD study director
Procare health Iberia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Libicare in people with Female Sexual Interest/Arousal Disorder, run by Procare Health Iberia S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of sexual desire and arousal (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188600, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.