Status:
UNKNOWN
Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
Lead Sponsor:
Kern Pharma, S.L.
Collaborating Sponsors:
Analysis and Research Network, S.L
Conditions:
Female Sexual Arousal Disorder
Eligibility:
FEMALE
45-65 years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 29 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03820453
Start Date
October 29 2018
End Date
August 29 2019
Last Update
January 29 2019
Active Locations (4)
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1
CAP Manso
Barcelona, Spain, 08015
2
Fundació Puigvert
Barcelona, Spain
3
Hospital Clínic, Barcelona
Barcelona, Spain
4
Sexology Institute
Barcelona, Spain