Condition category
Mental and Behavioural Disorders
Date applied
18/03/2019
Date assigned
28/03/2019
Last edited
02/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Women with low sexual desire may have problems when starting or having stable sexual relationships, and they may feel unsatisfied and experience marital disorders. Studies have demonstrated that women with low desire, low excitement, or sexual pain are clearly associated with negative feelings regarding their physical and emotional satisfaction, as well as their happiness. In addition, women suffering from those problems tend to experience much more negative emotions and psychological states than women with normal sexual activity.
Our objective was to study the effect of an extract with natural components on women with low sexual desire.
In this study, the multi-ingredient food supplement, Libicare®, has shown an improvement in desire, arousal, lubrication, orgasm, and sexual satisfaction domains, with a clear increase in free testosterone numbers and a decrease in SHBG levels in postmenopausal women.

Who can participate?
Postmenopausal women aged ≥ 45 and ≤ 65 (no natural menses for at least 1 year), with a stable partner and at risk of sexual dysfunction according to score of validated questionnaire.

What does the study involve?
All women were included at routine clinical visits and were treated with 2 tablets of Libicare®, one every 12 hours, daily for 2 months (9 weeks). Libicare® is an oral food supplement containing dry extracts of Trigonella foenum graecum, Turnera diffusa, Tribulus terrestris, and Ginkgo biloba.

What are the possible benefits and risks of participating?
All the participants have been informed, before their inclusion, of the possible risks and benefits, and of all the aspects of the study and have signed an Informed Consent expressing their willingness to participate.
Possible benefits: improving in sexual function.
Possible risks: due to characteristics of Libicare ingredients important risks were not expected.

Where is the study run from?
Instituto Palacios de Salud y Medicina de la Mujer, Madrid, Spain

When is the study starting and how long is it expected to run for?
August 2017 to November 2018

Who is funding the study?
Procare Health SL

Who is the main contact?
Dr Danial Khorsandi, danialkhorsandi92@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Danial Khorsandi

ORCID ID

http://orcid.org/0000-0002-5245-5555

Contact details

Passeig del Ferrocarril 339
Castelldefels
2nd floor
Barcelona
08860
Spain
+34617772262
khorsandi.d@procarehealth.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

LBC-0001

Study information

Scientific title

Effect of a multi-ingredient based food supplement on sexual function in women with low sexual desire. Pilot study.

Acronym

Study hypothesis

The Libicare® food supplement will improve sexual function in women.

Ethics approval

No approval needed.
The pilot study that has been presented has been carried out following a well-defined protocol, and in accordance with the main premises of Good Clinical Practices and the Declaration of Helsinki.

Study design

Observational prospective non-controlled pilot study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participants information sheet.

Condition

Female sexual dysfunction.

Intervention

All women were included at routine clinical visits and were treated with 2 tablets of Libicare®, one every 12 hours, daily for 2 months (9 weeks). Libicare® is an oral food supplement containing dry extracts of Trigonella foenum graecum, Turnera diffusa, Tribulus terrestris, and Ginkgo biloba. Libicare® is manufactured by Procare Health (Barcelona, Spain).

All participants were visited at baseline (initial visit) and after 9 weeks (final visit).
Primary variable: Total score of Female Sexual Function Index (FSFI) at 9 weeks vs baseline.
Secondary variables: FSFI score for each domain, and levels of free testosterone and sex hormone binding globulin at 9 weeks vs baseline.
Serum levels of free testosterone and sex hormone-binding globulin (SHBG) were measured in the LABCO Laboratory. SHBG was measured with chemiluminescent immunoassay Immulite 2000 XPi (Siemens Healthcare Diagnostics, Eschborn, Germany). The estimation of serum free testosterone hormone levels was carried out using the ELISA technique (The DiaMetra Italy kit (DKO-015))

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Sexual function measured using Female Sexual Function Index (FSFI) at 9 weeks vs baseline.

Secondary outcome measures

1. FSFI score for each domain at 9 weeks vs baseline.
2. Levels of free testosterone and sex hormone binding globulin at 9 weeks vs baseline.

Overall trial start date

01/05/2017

Overall trial end date

31/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy, postmenopausal women (no natural menses for at least 1 year) aged ≥ 45 and ≤ 65. Hysterectomized patients should have an FSH level above 40 IU.
2. Stable partner, living together for at least 15 days a month and being sexually available.
3. Risk of sexual dysfunction established at FSFI score< 25.83.
4. Integrity of the vaginal mucosa (without lesions or bleeding).
5. Women willing to and capable of understanding and signing an informed consent after receiving an explanation on the nature of the whole study.
6. Consenting to participate in the study and signing the Informed Consent form.
7. No desire for pregnancy in the next 3 months.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

This is a pilot study in which 29 patients were included

Total final enrolment

29

Participant exclusion criteria

1. Pregnant women or with suspected pregnancy.
2. Within 3 months following delivery or abortion.
3. Breastfeeding women.
4. Women with severe pain in sexual relationships (DMS-V).
5. Non-diagnosed abnormal genital bleeding or presence of vaginal lesions.
6. Women with symptoms of vaginal infection or signs of any other genital infection.
7. Women allergic or hypersensitive to the components of the study treatment.
8. Severe psychiatric disorder.
9. Use of any hormonal treatment with estrogens, progestogens, or estrogens and progestogens within 3 previous months prior to selection.
10. Use of any other drug or experimental device within 30 days prior to selection.
• Any condition preventing the patient from participating in the study, at the researcher’s discretion.

Recruitment start date

01/07/2017

Recruitment end date

30/01/2018

Locations

Countries of recruitment

Spain

Trial participating centre

Instituto Palacios de Salud y Medicina de la Mujer
Calle de Antonio Acuña, 9
Madrid
28009
Spain

Sponsor information

Organisation

Instituto Palacios de Salud y Medicina de la Mujer

Sponsor details

Calle de Antonio Acuña 9
Madrid
28009
Spain
915 78 05 17
ipalacios@institutopalacios.com

Sponsor type

Hospital/treatment centre

Website

https://institutopalacios.com/

Funders

Funder type

Industry

Funder name

Procare Health SL

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are going to publish a research paper in BMC woman's Health on July 2019

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/07/2019

Participant level data

Available on request

Basic results (scientific)

FSFI results are shown in Table below, which features the mean of baseline values and values after two months, with their standard deviations, of each domain, as well as global determination. As demonstrated by the results after treatment, values were significant for all domains except for dyspareunia. The domain presenting the highest increase was desire, with p=0.0004. The global domain increased 4.15 (6.14) points on average, with a statistical significance of p=0.0011.
TABLE
Mean at baseline Mean at 2 months Absolute change (mean) SS
Desire 2.40 (0.96) 3.33 (1.29) 0.93 (1.25) p=0.0004
Excitement 3.04 (0.96) 3.63 (1.44) 0.59 (1.25) p=0.0166
Lubrication 3.70 (0.98) 4.50 (1.34) 0.80 (1.34) p=0.0034
Orgasm 3.57 (1.14) 4.23 (1.43) 0.66 (1.30) p=0.0106
Sexual satisfaction 4.01 (0.99) 4.62 (1.22) 0.61 (1.45) p=0.0321
Dyspareunia 4.19 (1.06) 4.76 (1.40) 0.57 (1.55) p=0.0602
Global 20.42 (4.23) 25.08 (6.62) 4.15 (6.14) p=0.0011

Testosterone mean change between visits (post-pre) was an increase of 0.09 (SD 0.17) units (p=0.0386); the mean percent change as compared to baseline was 79.3% (p=0.0214).
Mean SHBG change between visits (post-pre) was a decrease of -12.05 (SD 11.48) units (p=0.0001).

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31039769 (added 02/05/2019)

Publication citations

Additional files

Editorial Notes

02/05/2019: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added. 29/03/2019: Internal review. 25/03/2019: Trial’s existence confirmed by Adknoma Health Research.