E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
PCOS is a common hormonal disorder in women. We wish to establish if the symptoms of PCOS can be improved by antidepressant therapy. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10014698 |
E.1.2 | Term | Endocrine disorders |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
HPA-axis activity measured by 24 hour-cortisole measurement and ACTH-test, and insuline sensitivity measured by euglycemic hyperinsulinemic clamp. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the beginning of the trial and after 12 weeks |
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E.5.2 | Secondary end point(s) |
Quality of life measured by questionnaires and physical activity measured by an accelerometer. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the beginning of the trial and after 12 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |