Polymorphism, Genetic Clinical Trial
— CAG-LibidoOfficial title:
Genetic Polymorphism of the Androgen Receptor-Gene and Sexual Function in Middle Aged Women
Verified date | September 2015 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
It is known that with increasing age sexual desire is declining in women. Decreasing levels
of androgens are believed to have an influence, but cannot explain the loss of libido
completely. A possible explanation might be that the effect of the androgen is depending on
the functionality of the androgen receptor. It is known that this functionality is
genetically determined by the polymorphism of the androgen receptor gene. In the gene there
is a varying number of CAG-repeats: the longer the CAG-Repeat, the lower the functionality
of the androgen receptor, the lower the effect of the androgens. In this pilot study, the
investigators would like to invite 45 healthy heterosexual middle-aged women to the
University Hospital of Bern, where they answer questionnaires about their sexual function
and where they give a blood sample to assess the testosterone serum levels and the
genetically determined androgen receptor subtype.
The investigators believe that lower androgen levels and/or longer CAG-repeats in the
androgen receptor gene are related to lower libido scores in healthy middle-aged women.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Female - Healthy - Heterosexual - Aged 45-65 - Written Informed Consent - Living since at least 1 year in a relationship - Ready to answer questionnaires about their sexual function - Ready to give a blood sample - German speaking Exclusion Criteria - Serious diseases such as Cancer, Parkinsons Disease, Multiple Sclerosis, Diabetes mellitus - Sexual Abuse in personal history - Thyroid dysfunction - Substance abuse (>1pack/cigarettes per day, alcohol, drugs) - Psychiatric diseases in personal history - Acute stressful life event - Libido affecting diseases such as dyspareunia, vaginism, orgasm disorders, urine incontinence - Medication with the following substances in the past 8 weeks before day of visit: - Systemic corticoids - Blood pressure medication with beta-blockers, spironolactone, thiazide diuretics - Psychotropic medication such as antidepressants, benzodiazepins, antiepileptics, antipsychotics (1st generation) - Opioid analgetics - Hormonal contraceptives - Libido stimulating medication such as androgens (Testosterone, Dehydroepiandrostendionsulfate, Dihydrotestosterone and PDE5-Inhibitants - Antiandrogens |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of gynaecological Endocrinology and reproduction medicine, Clinic for Gynaecology and Obstetrics, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | University Hospital Muenster, University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2 Subscores of the Female Sexual Function Index (FSFI): Satisfaction and Desire | 1 Day of visit | No | |
Secondary | Other 4 Subscores of the FSFI: Arousal, Lubrication, Orgasm and Pain | 1 Day of visit | No | |
Secondary | CAG-repeats of the androgen receptor gene | 1 Day of visit | No | |
Secondary | Testosterone serum levels | 1 Day of visit | No | |
Secondary | Androgenity score | Calculated from Gender-specific Index of Testosterone serum levels, CAG repeats and libido scores | 1 Day of visit | No |
Secondary | Other influences on libido in middle aged women | 1 Day of visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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