1. To examine and describe the vaginal microcirculation in patients with VA in comparison to patients without VA2. To examine and describe the effect of treatment with local oestrogen on the vaginal microcirculation.
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in measurements of microcirculatory parameters in patients with VA
and before and after treatment with local oestrogen.
Secondary outcome
n/a
Background summary
Vaginal atrophy (VA) is a condition that commonly affects postmenopausal women.
The aetiology of VA is mainly explained by the decline in levels of circulating
oestrogen associated with the menopausal transition, which causes the
epithelium of the vagina to become thin and friable. The role of the vaginal
microcirculation in the health of the vaginal epithelium is currently unknown.
Neither is known if possible damage to the vaginal microcirculation in women
with VA is reversible with the use of local oestrogen.
Study objective
1. To examine and describe the vaginal microcirculation in patients with VA in
comparison to patients without VA
2. To examine and describe the effect of treatment with local oestrogen on the
vaginal microcirculation.
Study design
An observational pilot study
Study burden and risks
Measurements will be performed in an outpatient clinic of a teaching hospital.
Patients will be counseled before the measurements and informed consent will be
obtained. The imaging probe will be covered with a sterile disposable cap. The
measurement technique is painless and will cause no harm.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Women with vaginal atrophy diagnosed based on:
a. The presence of one or more of the following symptoms:
- Vaginal dryness
- Vaginal itching/irritation
- Dyspareunia
b. The presence of one or more of the following symptoms on physical examination:
- Presence of vaginal wall pallor and petechiae
- Friability of the vaginal wall (defined as any bleeding occurring during examination)
- Conization (markedly decreased elasticity)
- Absence of rugae
Exclusion criteria
1. Previous pelvic surgery
2. Cardiovascular disease (e.g. angina pectoris, hypertension)
3. Inflammatory disease (e.g. rheumatoid arthritis, eczema)
4. Other systemic illness (e.g. (non-) insulin dependent diabetes mellitus)
5. Medications (e.g. anticoagulants, anti-inflammatory, or immunosuppressive agents) that could influence the microcirculation
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 | NL49119.018.14 |