Healthy volontary young women
Conditions
Interventions
Trade Name: Neovletta
Product Name: Neovletta
Product Code: Neovletta
Pharmaceutical Form: Capsule
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Current Sponsor code: NA
Other descriptive
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy young women; aged 18-35 years; BMI 19-30; regular menstrual cycle, willing to use oral contraceptive; non-smoking; good knowledge in Swedish; willing to use non-hormonal contraceptive during the study; willing to give informed consent in writing. 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 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Riskfactors for venous or arterial thrombosis; smoking; obesity; hypertension (blood pressure >130/90); diabetes mellitus; migraine with focal neurological symptoms; hepatic disease; depression; history of cancer or hereditary breast cancer; estrogen/gestagen therapy the last three months or other hormonal medication except for Levaxin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study effects of oral contraceptives on sexuality, well-being and economic behaviour in young women;Secondary Objective: To correlate behaviour to hormone levels and other serum markers;Primary end point(s): Sexual function, well-being and depressive symptoms and economic behaviour;Timepoint(s) of evaluation of this end point: Baseline and after three months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlations between primare outcomes and hormone levels;Timepoint(s) of evaluation of this end point: Baseline, after three months treatment and change | — |
Countries
Sweden
Contacts
Public ContactPrinciple Investigator
Karolinska University Hospital
Outcome results
None listed