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: 14.0 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Escitalopram
Product Name: Cipralex®
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Irregular menstruations (cyklus >35 days) or anovulation. Free testosterone > 0,035 nmol/l or facial hirsutism. BMI >25 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life measured by questionnaires and physical activity measured by an accelerometer.;Timepoint(s) of evaluation of this end point: At the beginning of the trial and after 12 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1)To investigate if treatment with cipralex will diminish the adrenal activity in PCOS patients versus placebo. 2)To investigate if quality of life, physical and menthal health improves, in PCOS patient on cipralex treatment versus placebo. ;Secondary Objective: 3)To investigate if insulin sensitivity, and with that, the cardiovascular risk profile, changes after 12 weeks of cipralex treatment. 4)To investigate if cipralex improves the daily physical activity, compared to placebo. ;Primary end point(s): HPA-axis activity measured by 24 hour-cortisole measurement and ACTH-test, and insuline sensitivity measured by euglycemic hyperinsulinemic clamp. ;Timepoint(s) of evaluation of this end point: At the beginning of the trial and after 12 weeks | — |
Countries
Denmark
Contacts
Public ContactDepartment of Endocrinology
Odense University Hospital
Outcome results
None listed