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van CCT (UK)

van CCT (UK)

Androgen sensitivity in women.

- candidate number8780
- NTR NumberNTR2654
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-dec-2010
- Secondary IDsP10-40 MEC
- Public TitleAndrogen sensitivity in women.
- Scientific TitleIdentification of psychometric and biological markers to assess androgen and serotonergic sensitivity in relation to sexual functioning in women.
- hypothesisTo evaluate variations of androgenicity and androgen (re) activity in (apparently) eugonadal women by using CAG repeat length polymorphism ([CAG]n) of the androgen receptor, free testosterone levels, 2D:4D ratio and attention for erotic stimuli (Stroop task) in relation to sexual functioning.
- Healt Condition(s) or Problem(s) studiedAndrogen sensitivity, Serotonergic sensitivity, Female sexual dysfunction
- Inclusion criteria1. Provision of written informed consent;
2. Female 21-70 years of age;
3. Healthy according to normal results of medical history;
4. Subject must be heterosexually oriented;
5. BMI ≥ 18 and ≤ 30 kg/m2;
6. Dutch as first language,
- Exclusion criteria1. Subjects who have had hand surgery interfering with measurement of digit lengths;
2. Subjects with musculoskeletal conditions affecting the measurements of digit lengths;
3. Known conditions associated with abnormal prenatal androgen exposure, namely congenital adrenal hyperplasia and complete androgen insensitivity syndrome;
4. Positive drug test and/or positive alcohol test;
5. Subjects with dyslexia;
6. Subjects who are color-blind;
7. Positive urine pregnancy test;
8. Use of oral contraception containing anti-androgens (e.g. Diane 35; Minerva);
9. Use of oral contraception containing 50 g estrogen or more;
10. Homosexual orientation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 6-dec-2010
- planned closingdate31-jan-2011
- Target number of participants200
- InterventionsAfter giving written informed consent and meeting the in- and exclusion criteria these subjects are enrolled in the study. The subjects will visit the study site once. An urine drug screening and alcohol breath test is performed, to exclude possible interference when performing the Stroop task. Also an urine pregnancy test will be performed to exclude the influence of pregnancy on the hormonal spectrum.
The visit to the study site will contain the following actions (in this order):
1. Giving written informed consent;
2. Urine drug analysis, pregnancy test and alcohol breath test;
3. Enrolment;
4. Stroop task;
5. Filling out questionnaires: SAQ, SFQ, SSEQ and SMQ;
6. Hand scan measuring the digit ratio;
7. Blood sample collected for determination of [CAG]n, genotype SERT and 5HT1a receptor and hormone spectrum.
- Primary outcome1. [CAG]n (blood);
2. Calculated second to fourth digit ratio (handscan);
3. Pre-attentional bias for erotic stimuli (Stroop task);
4. Blood serum free testosterone levels.
- Secondary outcome1. Blood serum levels ADT-G, 3-diol-G, DHEA and DHEA(s);
2. Genotype SERT and 5HT1a receptor (blood);
3. Questionnaires: SAQ, SSEQ and SMQ.
- TimepointsAll above mentioned outcomes (primary and secondary) are measured at the same visit, considering this study consists of only one visit for the subject. Methods are mentioned above as well.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Emotional Brain BV
- Funding
(Source(s) of Monetary or Material Support)
Alan Turing Institute Almere
- PublicationsN/A
- Brief summaryThis study is a cross-sectional study to evaluate androgenicity and androgen (re)activity in women by using attention for erotic stimuli (Stroop task) as well as CAG repeat length polymorphism of the androgen receptor, free testosterone levels and 2D:4D ratio in relation to sexual functioning. Sexual functioning is examined using the validated Sexual Functioning Questionnaire (42,43), a trait questionnaire measuring 7 domains of sexual functioning (desire, arousal-sensation,arousal-lubrication, pain, orgasm, enjoyment and partner), the Sexual Anamnesis Questionnaire (SAQ), which assesses sexual functioning, as described in the DSM-IV-TR, the Sexual Motivation Questionnaire (SMQ), a trait questionnaire measuring propensity for sexual excitation and sexual inhibition, and the Sexual Satisfaction of an Event Questionnaire (SSEQ), a state questionnaire measuring sexual satisfaction of a single sexual event. As a possible biological basis for maladaptive sexual inhibitory systems, polymorphisms of SERT and 5HT1a receptor are investigated.
The entire study will be performed in the Netherlands,
- Main changes (audit trail)
- RECORD15-dec-2010 - 27-dec-2010

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