Female Sexual Arousal Disorder
Conditions
Brief summary
This clinical Trial will assess the effects of a dietary supplement based on Tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the FSFI scale and different variables during 3 months period. Participants will be allocated to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks and at 24 weeks optional).
Interventions
DIETARY_SUPPLEMENTTribulus Terrestris
The experimental arm will receive a dietary supplement to increase the libido and sexual function
OTHERPlacebo treatment
The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics
Sponsors
Analysis and Research Network, S.L
Kern Pharma, S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria * Post-menopause. * Age between 45 and 65 years. * Sexually active. * Agreement to participate and to sign the informed consent documents.
Exclusion criteria
* Pregnancy. * Women who are on hormone replacement therapy or who need to start it. * Cancer treatment or a recent history of cancer (\<2 years). * Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible) * Fibromyalgia. * Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.). * Any comorbidity that may interfere with the pathology under study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Score on the Female Sexual Function Index (FSFI) | At baseline, at 6 weeks, at 3 months and at 6 months (optional) | Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido. The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome. Scale subdomains, their scoring range and factor to the total score is the following: Domain: Desire, Range \[1 - 5\] Factor: 0.6 Domain: Arousal, Range \[0 - 5\] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range \[0 (or 1) - 5 \] Factor: 0.4 Domain: Pain Range \[0-5\] Factor: 0.4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life (QoL) - Measured with Score on the Cervantes Scale. | Change from baseline, to 3 months and optional visit at 6 months | Score on the Cervantes Scale on quality of life. The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value. |
| Number of adverse events | Thought the study, an average of 10 months. | Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product |
| Variations in testosterone levels (total, bioavailable, and free) | Change from baseline to 3 months visit | Testosterone levels (total, bioavailable and free) in blood |
| Compliance with treatment - Recount of refounded product by patient. | 3 months | Recount of product returned at the end of study |
| Compliance with treatment -Therapeutic adherence | 3 months | Data will be collected by the investigator at participants visit with a unique question about percentage of intake. It will be considered a good compliance if 80% of the medication has been taken. |
| Compliance with treatment - Measured with the Morisky-Green scale | 3 months | The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1. Possible result values for the scale goes from 0 to 4 with 4 being a better outcome than 0. |
Countries
Spain
Outcome results
None listed