The aim of this study is to investigate whether conjugated androgen metabolites (i.e. 3α-diol-G and ADT-G) could serve as a biomarker for increased androgen exposure in women with hirsutism, irrespective of serum T and A4 levels. The second aim of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Endocriene aandoeningen van de bijnier/gonadale functie/perifere weefsels
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Conjugated androgen metabolites: 3α-diol-3G, 3α-diol-17G, ADT-G
- 3G/17G-ratio
Secondary outcome
- Results of the psychological questionnaire
- HOMA-index (serum measurement)
- HbA1c, fasting insulin and glucose
- Lipid profile (serum total cholesterol, LDL, VLDL, HDL, triglycerides)
- Liver enzymes (serum ALP, ALT, AST, GGT, ELF)
Background summary
Hirsutism, the excessive growth of terminal hair in a man-like pattern in a
female, is the most important clinical sign of androgen excess in women.
However, not all patients with hirsutism have elevated serum levels of
testosterone (T) or androstenedione (A4), which is called idiopathic hirsutism
(IH). This is explained by the fact that the majority of androgens in women are
produced in the same peripheral tissue cells as where they exert their action
in (e.g. the skin), with only a minimal release of T and A4 into the general
circulation. However, conjugated androgen metabolites do diffuse into the
general circulation where they can be measured before elimination by the
kidneys. Conjugated androgen metabolites, such as 3α-androstanediol glucuronide
(3α-diol-G) and androsterone glucuronide (ADT-G), have previously been
discussed to reflect peripheral androgen exposure, and could therefore serve as
a better biomarker for androgen exposure in IH.
Our hypothesis is that conjugated androgen metabolites could serve as a
biomarker for increased androgen exposure in women with hirsutism, irrespective
of serum T and A4 levels. If so, patients with IH might also benefit from
anti-androgenic medication.
Study objective
The aim of this study is to investigate whether conjugated androgen metabolites
(i.e. 3α-diol-G and ADT-G) could serve as a biomarker for increased androgen
exposure in women with hirsutism, irrespective of serum T and A4 levels. The
second aim of this study is to investigate whether hirsutism is associated with
a decreased metabolic, cardiovascular and psychological health.
Study design
A case control study.
Study burden and risks
First, participants will be asked to complete a short survey containing
questions about one*s presence of excessive hair growth, menstrual pattern,
evident endocrine diagnoses and medicine use. This survey is the first step of
our screening and selection procedure and will be used to characterize the
participants and to establish the likelihood of having polycystic ovary
syndrome (PCOS). Based on the survey, we will invite 20 women with hirsutism
and PCOS and 20 women with hirsutism without PCOS. In addition, we will recruit
40 control women from the general population.
In all these 80 subjects we will assess hair growth on four different locations
on the skin (i.e. upper lip, chin, lower abdomen and thighs) with a validated
digital microscope camera. Furthermore, four tubes of blood (22 mL in total)
will be drawn through venous blood sampling. The measurement of endocrine
laboratory parameters is the second step in our selection procedure and aims to
characterize our patients biochemically. Finally, participants will be asked to
complete one questionnaire concerning their psychological wellbeing (degree of
depression, anxiety and overall quality of life) and more specific questions
concerning the psychological impact of (excessive) hair growth. The risks of
participation are considered negligible.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Premenopausal women (18-40 years) with hirsutism:
- Ability to provide informed consent;
- Ability to speak and understand Dutch;
- The presence of hirsutism.
Healthy premenopausal women (18-40 years):
- Ability to provide informed consent;
- Ability to speak and understand Dutch;
- Consider themselves healthy; no signs of hirsutism, hyperandrogenism or other
endocrine pathologies.
Exclusion criteria
Premenopausal women (18-40 years) with and without hirsutism:
- Primary ovarian insufficiency (POI) or premature ovarian failure (POF);
- Pregnancy;
- Any of the following medications:
o Oral contraceptives
o Anocrine/danazol;
o Minoxidil;
o Fluoxetine;
o Celestone;
o Dexamethasone;
o Hydrocortisone;
o (Methyl)prednisolone;
o Prednisone;
o Spironolactone;
o Flutamide;
o Finasteride;
o Cimetidine;
o Anabolic steroids.
Design
Recruitment
Medical products/devices used
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 | NL85783.018.24 |