The effect of antidepressant therapy on quality of life, physical and menthal health and stress hormone metabolism in PCOS.
- Conditions
- Polycystic Ovary Syndrome, PCOS, is the most common endocrine disorder in fertile women. Insuliresistance, hirsutism, hyperandrogenemia, adipositas, high cortisole levels and infertility are frequent symptomes who also intervene with the quality of life. We want to investigate a possibilit for improvement of the symptoms with cipralex.MedDRA version: 14.0Level: SOCClassification code 10014698Term: Endocrine disordersSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2010-022319-20-DK
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Irregular menstruations (cyklus >35 days) or anovulation.
Free testosterone > 0,035 nmol/l or facial hirsutism.
BMI >25 and < 40 kg/m2.
Age 18-45 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Postmenopausal
Fasting plasma glucose >7 mmol/l or HbA1c >6,3 %
Endokrine or other medical treated disease.
Eating disorder or known medical treated psychiatric disorder.
Medical use, known to intervene with the parametres used in the trial, up to 3 moths prior.
Pregnancy or planed pregnancy in the treatment period.
Non-kaukasian
Epilepsi
Bleeding tendensy
Cardiovascular disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method