The aims of this prospective study are to investigate:1a: Changes in menopausal symptoms and biochemical changes as result of PBSO in premenopausal women.1b: Changes in menopausal symptoms and biochemical changes as result of PBSO in postmenopausal…
ID
Source
Brief title
Condition
- Reproductive tract and breast disorders congenital
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endocrine symptoms score
Hot flush score
Estrogens, Testosterone, DHEAS, Serotonine, 5-HT2A-receptor
Secondary outcome
Sexual functioning score
Depression and anxiety score
Progesterone, LH, FSH, Cortisol, SHBG, Prolactin, Oxytocin, Catecholamines and
β-Endorphin
Background summary
A recent study found that the effectiveness of Hormonal Replacement Therapy
(HRT) for alleviating endocrine and/or sexual complaints and quality of life
was of limited importance for surgically postmenopausal women. An explanation
for this effect may be found in the hypothalamic-pituitary-adrenal axis (HPA
axis) and the hypothalamic-pituitary-gonadal axis (HPG axis). The possible
differences on the various hormone concentrations of sex hormones or
neurotransmitters between surgically and naturally postmenopausal women could
be an explanation for the results of HRT by these women.
Study objective
The aims of this prospective study are to investigate:
1a: Changes in menopausal symptoms and biochemical changes as result of PBSO in
premenopausal women.
1b: Changes in menopausal symptoms and biochemical changes as result of PBSO in
postmenopausal women.
2: Difference in intensity of menopausal symptoms and related biochemical
parameters between surgically and naturally postmenopausal women (control group
2).
3: The effect of HRT in alleviating menopausal complaints and related
biochemical parameters in surgically postmenopausal women compared to naturally
postmenopausal women (control group 1).
4: Difference in menopausal symptoms and related biochemical parameters in
surgically postmenopausal women between HRT and non-HRT users.
5: The prevalence of serotonin receptor (5-HT2A receptor) and serotonin
polymorphism (5-HTTLPR) in surgically postmenopausal women with respect to the
effect of HRT use.
Study design
Prospective observational and longitudinal study
Study burden and risks
Group1: 4 times blood donations and 3 questionnaires
Group2: 2 times blood donations and 2 questionnaires
Group3: Once blood donation and 1 questionnaire
Plesmanlaan 121
1066CX
Nederland
Plesmanlaan 121
1066CX
Nederland
Listed location countries
Age
Inclusion criteria
gr 1) Eligible to undergo PBSO
Either proven BRCA 1 or BRCA 2 mutation carrier or member of an HBOC-
family
gr 2) Last menses >3 months ago
Menopausal complaints
gr 3) Age>=46 and <56 years
Last menses >3 months, <3 years
Exclusion criteria
gr 2 : Hormone use (contraceptives or HRT)
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 | NL11371.031.06 |