Veeda has established
a reputation for being able to perform a
wide range of studies in the women’s health
area and we consider ourselves to be one of
the premier units working in this area in
the UK.
In the UK we have a large population of
female subjects who are taking the oral
contraceptive pill, surgically sterilised
females and also older ladies who are
post-menopausal. The Unit has particular
experience with gynaecological studies and
has a gynaecological suite. We have
performed diverse studies including cell
sampling and uterine biopsy and vaginal
ultrasound. We are also familiar with the
evaluation of patches in drug
administration. The large younger female
population is also used extensively for
gender balance even in simple
pharmacokinetic studies. |
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| FACILITIES |
Veeda’s Phase I clinic is located in
Plymouth in the South West of the UK. The
location of our unit has several advantages: |
- We are the only Phase I unit in the
area, the nearest unit is over 150 miles
away by road
- Our unit has a mixture of
conventional monitored wards and
smaller, 2-3 bedded rooms where subjects
can be housed for the non-intensive
parts of the study
- Plymouth is a naval city; this means
that women are often at home alone for
long periods of time and taking part in
a study can provide an opportunity to
socialise with other women in similar
circumstances
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DATABASE OF SUBJECTS
Veeda currently has a database of around
2100 active female subjects. Most of these
subjects (60%) are non-sterilised females
aged 18-45 years but we also have good
populations of young, sterilised females
aged 18-45 years, post-menopausal females
aged 46-64 years and elderly females aged
65-85 years. |
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| EXPERIENCE |
Veeda’s unit in Plymouth has experience of
a wide range of studies in female
populations. Some examples of studies
performed in our unit recently are: |
- Administration of cream containing test drug to the cervix of sterilised females
- Measurement of intra-urethral
sphincter pressure by indwelling
pressure transducer in pre-menopausal,
parous females
- Dosing sterilised females of
child-bearing age according to menstrual
cycle and follicle size (as measured by
trans-vaginal ultrasound)
- Study in females taking oral
contraceptives involving trans-vaginal
ultrasound examination of the ovaries
and down regulation of FSH and LH prior
to dosing
- Oral Contraceptive interaction
studies
- Two studies in young female subjects
where dosing was determined by menstrual
cycle
- Study looking at excretion of test
drug in lactating women
- Study in post-menopausal females
which included mammography, cervical
smears and Biolog hot flush measurements
- Several pharmacokinetic studies in
post-menopausal females
- Ovulation interaction studies
|
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| SPECIFIC EXPERTISE |
In support of our studies in this area,
Veeda has experience of a wide range of
specialist techniques including: |
- Ultrasound imaging: This enables us
to study the uterine lining, uterus and
ovaries and also to perform regional
blood flow studies using colour Doppler
imaging
- Flexible hysteroscopy and biopsy
- Colposcopy
- Pipelle sampling
- Assessment of menstrual blood loss
- Use of diaries of various types to
track symptoms, menses and other
parameters
- Hormone and biomarker assays: Veeda
has experience of measuring a wide range
of hormones and other biomarkers in this
area including FSH, LH, Oestradiol and
Prolactin
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