Genetic Polymorphism of the Androgen Receptor-Gene and Sexual Function in Middle Aged Women

NCT01977313 | Completed

• 1 other identifier: 087/13
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Libido; Receptors, Androgen; Polymorphism, Genetic; Androgen Effect

Outcome Measures

Primary Outcomes (1)

• 2 Subscores of the Female Sexual Function Index (FSFI): Satisfaction and Desire

  1 Day of visit

Secondary Outcomes (5)

• Other 4 Subscores of the FSFI: Arousal, Lubrication, Orgasm and Pain

  1 Day of visit

• CAG-repeats of the androgen receptor gene

  1 Day of visit

• Testosterone serum levels

  1 Day of visit

• Androgenity score

  1 Day of visit

• Other influences on libido in middle aged women

  1 Day of visit

Study Arms (1)

All study participants

All study participants

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A community sample of 45 healthy heterosexual women, aged 45-65.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital Muenster: collaborator
• University of Zurich: collaborator

Study Sites (1)

Dep. of gynaecological Endocrinology and reproduction medicine, Clinic for Gynaecology and Obstetrics, Bern University Hospital

Bern, 3010 Bern, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Bulbo-Spinal Atrophy, X-Linked

Condition Hierarchy (Ancestors)

Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Petra Stute, PD Dr. med.

  Clinic for Gynaecology and Obstetrics, Insel University Hospital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

CH (1)