LibidoCAG-LibidoNCT01977313
Genetic Polymorphism of the Androgen Receptor-Gene and Sexual Function in Middle Aged Women
An observational study of Libido and Receptors, Androgen, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Libido, Receptors, Androgen, Polymorphism, Genetic
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A community sample of 45 healthy heterosexual women, aged 45-65.
Who may be able to join
- Female
- Healthy
- Heterosexual
- Aged 45-65
- Written Informed Consent
- Living since at least 1 year in a relationship
Show all 9Show fewer
- Ready to answer questionnaires about their sexual function
- Ready to give a blood sample
- German speaking
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of gynaecological Endocrinology and reproduction medicine, Clinic for Gynaecology and Obstetrics, Bern University Hospital
Bern, 3010 Bern
About this study
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.
Read the detailed description
Background
It is known that with increasing age sexual desire is declining in women. Multiple factors are being discussed to have an influence on this topic, such as cultural, individual and biological factors. Decreasing levels of sexual hormones and specifically androgens are believed to have an influence, hence a lot of women benefit from a testosterone replacement therapy. Yet the sole decline of androgen levels with inclining age cannot explain the loss of libido completely.
A possible further factor might be the androgen receptor: It is known that the effect of the androgen in its target cells is depending on the functionality of the androgen receptor. This functionality is genetically determined by the polymorphism of the androgen receptor gene: In the gene there is a sequence with a varying number of CAG-repeats. This CAG-repeat is coding for a polyglutamine stretch in the androgen receptor which is responsible for the binding of co-activator proteins. The better these co-activator proteins are bound to the androgen receptor, the better the transcriptional activity of the latter. Previous studies have shown that the longer the CAG-Repeat, the weaker the binding of co-activator proteins, the lower the functionality of the receptor and therefore the lower the effects of the androgen on the target cell. Given this circumstances the same level of androgen can have different effects in two individuals.
Objective
In this pilot study, the investigators would like to correlate the testosterone serum levels, the functionality of the androgen receptor and the libido in 45 healthy, heterosexual middle-aged women.
Methods
45 healthy middle-aged women are being recruited and are being invited to come to the University Hospital in Berne. Here they will answer standardised questionnaires about their sexual function and libido and will give a blood sample to measure all the relevant parameters (fasting, premenopausal women: 1.-5. day of cycle): Total Testosterone, SHBG, Estrogen, DHEAS, FSH, LH, CAG repeats of the androgen receptor gene, TSH, fT3, fT4, Prolactin, Ferritin, CRP, Hemoglobin.
A statistician will then assess the collected data. No interventions are planned.
The following collaborators are providing support for this study: Dr. rer. nat. Ulrich Stefenelli, Würzburg, Germany, and Dr. med. Stefan Schmid, Rheinfelden, Switzerland.
- Conditions
- Libido, Receptors, Androgen, Polymorphism, Genetic, Androgen Effect
- Medical subject headings
- Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | All study participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Subscores of the Female Sexual Function Index (FSFI): Satisfaction and Desire
Measured: 1 Day of visit
Secondary outcomes (5)
Other 4 Subscores of the FSFI: Arousal, Lubrication, Orgasm and Pain
Measured: 1 Day of visit
CAG-repeats of the androgen receptor gene
Measured: 1 Day of visit
Testosterone serum levels
Measured: 1 Day of visit
Androgenity score
Calculated from Gender-specific Index of Testosterone serum levels, CAG repeats and libido scores
Measured: 1 Day of visit
Other influences on libido in middle aged women
Measured: 1 Day of visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LibidoStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Muenster, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Petra Stute, PD Dr. med., Principal investigator, Clinic for Gynaecology and Obstetrics, Insel University Hospital Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977313
- Sponsor's protocol ID
- 087/13
- Acronym
- CAG-Libido
- Status last verified
- Sep 2015
- First submitted
- 30 Oct 2013
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphism of the Androgen Receptor-Gene and Sexual Function in Middle Aged Women
- ClinicalTrials.gov ID
- NCT01977313
- Acronym / sponsor ID
- CAG-Libido / 087/13
- Conditions
- Libido, Receptors, Androgen, Polymorphism, Genetic, Androgen Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University Hospital Muenster, University of Zurich
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
It is known that with increasing age sexual desire is declining in women. Multiple factors are being discussed to have an influence on this topic, such as cultural, individual and biological factors. Decreasing levels of sexual hormones and specifically androgens are believed to have an influence, hence a lot of women benefit from a testosterone replacement therapy. Yet the sole decline of androgen levels with inclining age cannot explain the loss of libido completely.
A possible further factor might be the androgen receptor: It is known that the effect of the androgen in its target cells is depending on the functionality of the androgen receptor. This functionality is genetically determined by the polymorphism of the androgen receptor gene: In the gene there is a sequence with a varying number of CAG-repeats. This CAG-repeat is coding for a polyglutamine stretch in the androgen receptor which is responsible for the binding of co-activator proteins. The better these co-activator proteins are bound to the androgen receptor, the better the transcriptional activity of the latter. Previous studies have shown that the longer the CAG-Repeat, the weaker the binding of co-activator proteins, the lower the functionality of the receptor and therefore the lower the effects of the androgen on the target cell. Given this circumstances the same level of androgen can have different effects in two individuals.
Objective
In this pilot study, the investigators would like to correlate the testosterone serum levels, the functionality of the androgen receptor and the libido in 45 healthy, heterosexual middle-aged women.
Methods
45 healthy middle-aged women are being recruited and are being invited to come to the University Hospital in Berne. Here they will answer standardised questionnaires about their sexual function and libido and will give a blood sample to measure all the relevant parameters (fasting, premenopausal women: 1.-5. day of cycle): Total Testosterone, SHBG, Estrogen, DHEAS, FSH, LH, CAG repeats of the androgen receptor gene, TSH, fT3, fT4, Prolactin, Ferritin, CRP, Hemoglobin.
A statistician will then assess the collected data. No interventions are planned.
The following collaborators are providing support for this study: Dr. rer. nat. Ulrich Stefenelli, Würzburg, Germany, and Dr. med. Stefan Schmid, Rheinfelden, Switzerland.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | –All study participants |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A community sample of 45 healthy heterosexual women, aged 45-65.
Key inclusion criteria (9 listed)
- Female
- Healthy
- Heterosexual
- Aged 45-65
- Written Informed Consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2 Subscores of the Female Sexual Function Index (FSFI): Satisfaction and Desire
Time frame: 1 Day of visit
5 secondary outcomes
Other 4 Subscores of the FSFI: Arousal, Lubrication, Orgasm and Pain
Time frame: 1 Day of visit
CAG-repeats of the androgen receptor gene
Time frame: 1 Day of visit
Testosterone serum levels
Time frame: 1 Day of visit
Androgenity score
Time frame: 1 Day of visit
Other influences on libido in middle aged women
Time frame: 1 Day of visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Stute, PD Dr. med. principal investigator
Clinic for Gynaecology and Obstetrics, Insel University Hospital Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Libido and Receptors, Androgen, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Subscores of the Female Sexual Function Index (FSFI): Satisfaction and Desire (time frame: 1 Day of visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.