Effect of a food supplement on sexual function in women with low sexual desire
| ISRCTN | ISRCTN12928573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12928573 |
| Secondary identifying numbers | LBC-0001 |
- Submission date
- 18/03/2019
- Registration date
- 28/03/2019
- Last edited
- 02/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Passeig del Ferrocarril 339
Castelldefels
2nd floor
Barcelona
08860
Spain
 ORCID ID |
0000-0002-5245-5555 |
|---|---|
| Phone | +34617772262 |
| khorsandi.d@procarehealth.com |
Study information
| Study design | Observational prospective non-controlled pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participants information sheet. |
| Scientific title | Effect of a multi-ingredient based food supplement on sexual function in women with low sexual desire. Pilot study. |
| Study objectives | The Libicare® food supplement will improve sexual function in women. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2017 |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | This is a pilot study in which 29 patients were included |
| Total final enrolment | 29 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/07/2017 |
| Date of final enrolment | 30/01/2018 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28009
Spain
Sponsor information
Hospital/treatment centre
Calle de Antonio Acuña 9
Madrid
28009
Spain
| Phone | 915 78 05 17 |
|---|---|
| ipalacios@institutopalacios.com | |
| Website | https://institutopalacios.com/ |
"ROR" |
https://ror.org/01kvepn75 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We are going to publish a research paper in BMC woman's Health on July 2019 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/04/2019 | 02/05/2019 | Yes | No |
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.
