Primary Objective: The primary objective is to study clitoral volume changes during sexual arousal in premenopausal women compared to postmenopausal women.Secondary Objective(s) are: To study whether there is an association between feelings of…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is clitoral volume during sexual arousal assessed by MRI
in healthy pre and postmenopausal women.
Secondary outcome
Secondary endpoints are self-reported feelings of sexual arousal during
audiovisual sexual stimulation (erotic film), and sexual function assessed by a
validated sexual function questionnaire with the addition of items about
orgasmic functioning.
Background summary
Although the full anatomy of the clitoris was presented by O*Connell (O*Çonell
et al. 1998), few people are aware of the three-dimensional structure of this
organ, let alone of the exact size of the clitoris and its ability to become
erect as a result of sexual arousal. Typical textbook descriptions of the
clitoris lack detail and often include inaccuracies. Only a small number of
scientific papers are available on size measurements and the increase in
clitoral volume during sexual arousal. Moreover, there is a lack of research on
the association of the clitoral sexual arousal response and sexual functioning.
Population studies show that about 30% of women suffer from sexual
dysfunctions, with a higher prevalence in postmenopausal women. It is not yet
known how the clitoris size and ability to swell correlates with sexual
functioning and if menopause influences the clitoris ability to swell during
sexual arousal.
Study objective
Primary Objective: The primary objective is to study clitoral volume changes
during sexual arousal in premenopausal women compared to postmenopausal women.
Secondary Objective(s) are:
To study whether there is an association between feelings of sexual arousal
during audiovisual sexual stimulation and clitoral volume or percentage change
in clitoral volume during audiovisual sexual stimulation.
To study whether there is an association between self-reported sexual function
and clitoral volume or percentage change in clitoral volume during audiovisual
sexual stimulation.
Study design
This is an observational cohort case-control study with non-invasive
measurements.
Participants receive questionnaires and magnetic resonance imaging (MRI) during
watching of an erotic filmclip during a single occasion.
Study burden and risks
Changes in clitoral volume during sexual arousal in pre and postmenopausal
women, and its association with sexual function is an understudied subject.
Knowledge on clitoral responses during sexual arousal and possible pre and
postmenopausal differences in clitoral volume will yield benefits for the
general population in increasing knowledge on female sexual functioning
facilitating female sexual pleasure and health, and for health professionals
treating patients with sexual dysfunction.
The risks associated with this study are small: they are related to possible
intruding questions on sexual arousal and discomfort associated with MRI
testing. We think that a clear subject information sheet, as well as verbal
explanation, should inform the subject sufficiently on the study procedures.
Altogether, the set-up of our study allows us to collect unique information on
clitoral volume changes during sexual arousal in pre and postmenopausal women.
Connecting the experimental data to sexual function data, results in a positive
balance of benefits as compared to the possible risks of this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Adult, >18 years of age
- Able to give written informed consent
- Having a primarily heterosexual orientation
- Having a stable, sexually active relationship for at least the preceding 6
months
In addition, for premenopausal women:
- Age < 45 and having a regular menstrual cycle.
In addition, for postmenopausal women:
- Age > 45 years, and no menstruation since at least one year, after a
previously regular menstrual cycle. No use, or recent (in the prior 6 months)
use of estrogen, hormonal medication, or hormonal contraception.
Exclusion criteria
- Use, or recent (in the prior 6 months) use, of psychotropic medication
- Acute or chronic medical or mental conditions with a known effect on sexual
response
- Current pregnancy or delivery within the last 12 months
- History of hysterectomy or vaginal surgery, gynecologic disease or
malignancy, pelvic inflammatory disease or vaginal infection and known
anatomical abnormalities of the genitalia.
- Contra-indications to MRI (metal implants, pacemakers, claustrophobia, etc.).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83064.018.22 |