Female Sexual DysfunctionLIBIDOBSNCT04124640
Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction.
An observational study of Female Sexual Dysfunction, run by Procare Health Iberia S.L. at 1 site in Spain.
Trial summary
The decrease or absence sexual desire and arousal is the alteration of the sexual sphere that women most commonly refer to in adulthood and old age. Many women can refer a decrease or absence of desire and / or arousal without having the disorder typified in the DSM-5, but that can cause discomfort, worry and… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Patients' data (baseline characteristics, clinical and outcomes) from routine care visits
- How many people
- 185 participants
- Where
- 1 siteSpain
- Study dates
- 29 Oct 2019to 15 Nov 2021
- Phase
- Observational
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal
Who may be able to join
- Women between 45 and 65 years old, both ages included.
- Women who refer decreased desire and / or sexual arousal.
- Women who will receive LIBICARE® by prescription of their doctor regardless of their participation or not in the study.
- Women who have given their informed consent in writing.
Who cannot join
- Women who suffer or have suffered breast cancer.
- Women in anticoagulant treatment.
- Women who, in the opinion of the researcher, cannot follow the study procedures.
- Women not be able to understand the nature of the study, the procedures to follow or who are not authorized to sign an informed consent
- Pregnant or lactating women
- Women with allergies to any of the components of Libicare®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study in Real Life to Describe the Effectiveness of LIBICARE® in Women With Low Arousal and Sexual Desire Levels.
The decrease or absence sexual desire and arousal is the alteration of the sexual sphere that women most commonly refer to in adulthood and old age. Many women can refer a decrease or absence of desire and / or arousal without having the disorder typified in the DSM-5, but that can cause discomfort, worry and relationship problems in their day to day. Libicare® is a food supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels. The main ingredients of Libicare® are:
- Trigonella Foenum-graecum (Trigonella) (1)
- Tribulus Terrestris (Tribulus) (2)
- Turnera Diffusa (Damiana) (3)
Read the detailed description
The main objective is to describe the effectivity of LIBICARE® in the improvement of desire and sexual arousal in women between 45 and 65 years old, in real life.
The secondary objectives of the study are:
- Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.
- Assessment of the safety of LIBICARE® by collecting serious and non-serious adverse events.
- Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.
- Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.
- Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.
- To evaluate the degree of usefulness of the EVAS-M scale in clinical practice after 4 months of treatment.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Patients' data (baseline characteristics, clinical and outcomes) from routine care visits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients' data (baseline characteristics, clinical and outcomes) from routine care visitsOther
Use of a standardized scale to collect clinical and patient-centered data, to assess the effectiveness of Libicare in real life in female 45-65 years old. Patients' data (baseline characteristics, clinical and outcomes) will be collected according to sites routine care.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal Receives: Other: Patients' data (baseline characteristics, clinical and outcomes) from routine care visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.
The effectiveness will be the increase in the score of the EVAS-M scale that will be provided to patients in the visita during the follow-up visits.
Measured: 4 month
Secondary outcomes (6)
Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.
Evaluation of the 6 domains of the EVAS-M scale ("Escala de Valoración de la Actividad Sexual en la mujer" in Spanish, score from 2 to 60 points) at 2 and 4 months of treatment
Measured: at 2 and 4 months of treatment
Evaluation of the safety of LIBICARE® by collecting serious and non-serious adverse events.
The safety that will be defined by the serious and non-serious adverse reactions collected throughout the study.
Measured: at 4 months of treatment
Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.
Evaluation of patient satisfaction with treatment using the Likert scale
Measured: at 2 and 4 months of treatment
Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.
Therapeutic compliance will continue to be adjusted as much as possible to routine clinical practice using the Likert scale
Measured: at 2 and 4 months of treatment
Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.
Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine care
Measured: at 0, 2 and 4 months of treatment
To evaluate the degree of usefulness of the EVAS-M (ESCALA DE VALORACION DE LA ACTIVIDAD SEXUAL in Spanish) scale in clinical practice after 4 months of treatment.
Usefulness of using the EVAS-M scale in clinical practice (last visit)
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start29 Oct 2019
- Primary completion31 Dec 2020
- Study completion15 Nov 2021
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 DysfunctionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 185 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 IberiaSantiago Palacios, Principal investigator, Instituto Palacios de Salud y Medicina de la Mujer.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124640
- Sponsor's protocol ID
- PRO-LIB-2019-01
- Acronym
- LIBIDOBS
- Status last verified
- Dec 2022
- First submitted
- 19 Jun 2019
- Last updated
- 2 Dec 2022
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Real Life to Describe the Effectiveness of LIBICARE® in Women With Low Arousal and Sexual Desire Levels.
- ClinicalTrials.gov ID
- NCT04124640
- Acronym / sponsor ID
- LIBIDOBS / PRO-LIB-2019-01
- Conditions
- Female Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 11 Oct 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 decrease or absence sexual desire and arousal is the alteration of the sexual sphere that women most commonly refer to in adulthood and old age. Many women can refer a decrease or absence of desire and / or arousal without having the disorder typified in the DSM-5, but that can cause discomfort, worry and relationship problems in their day to day. Libicare® is a food supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels. The main ingredients of Libicare® are:
- Trigonella Foenum-graecum (Trigonella) (1)
- Tribulus Terrestris (Tribulus) (2)
- Turnera Diffusa (Damiana) (3)
Detailed description
The main objective is to describe the effectivity of LIBICARE® in the improvement of desire and sexual arousal in women between 45 and 65 years old, in real life.
The secondary objectives of the study are:
- Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.
- Assessment of the safety of LIBICARE® by collecting serious and non-serious adverse events.
- Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.
- Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.
- Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.
- To evaluate the degree of usefulness of the EVAS-M scale in clinical practice after 4 months of treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | – | Other: Patients' data (baseline characteristics, clinical and outcomes) from routine care visitsThe study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be women between 45 and 65 years old, both ages included, who present a decrease in sexual desire or arousal
Key inclusion criteria (4 listed)
- Women between 45 and 65 years old, both ages included.
- Women who refer decreased desire and / or sexual arousal.
- Women who will receive LIBICARE® by prescription of their doctor regardless of their participation or not in the study.
- Women who have given their informed consent in writing.
Key exclusion criteria (6 listed)
- Women who suffer or have suffered breast cancer.
- Women in anticoagulant treatment.
- Women who, in the opinion of the researcher, cannot follow the study procedures.
- Women not be able to understand the nature of the study, the procedures to follow or who are not authorized to sign an informed consent
- Pregnant or lactating women
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 |
|---|---|---|
| Patients' data (baseline characteristics, clinical and outcomes) from routine care visitsUse of a standardized scale to collect clinical and patient-centered data, to assess the effectiveness of Libicare in real life in female 45-65 years old. Patients' data (baseline characteristics, clinical and outcomes) will be collected according to sites routine care. | Other | treatment group |
Primary outcome
To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life.
Time frame: 4 month
The effectiveness will be the increase in the score of the EVAS-M scale that will be provided to patients in the visita during the follow-up visits.
6 secondary outcomes
Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.
Time frame: at 2 and 4 months of treatment
Evaluation of the safety of LIBICARE® by collecting serious and non-serious adverse events.
Time frame: at 4 months of treatment
Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.
Time frame: at 2 and 4 months of treatment
Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.
Time frame: at 2 and 4 months of treatment
Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.
Time frame: at 0, 2 and 4 months of treatment
To evaluate the degree of usefulness of the EVAS-M (ESCALA DE VALORACION DE LA ACTIVIDAD SEXUAL in Spanish) scale in clinical practice after 4 months of treatment.
Time frame: at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- 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
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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
Santiago Palacios principal investigator
Instituto Palacios de Salud y Medicina de la Mujer.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Sexual Dysfunction, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 Dec 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To describe the effectiveness of LIBICARE® in improving sexual desire and arousal in women between 45 and 65 years of age, in real life. (time frame: 4 month). 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 NCT04124640, 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 2 Dec 2022.