E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy women |
Friska kvinnor |
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E.1.1.1 | Medical condition in easily understood language |
Healthy women |
Friska kvinnor |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030970 |
E.1.2 | Term | Oral contraception |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
to prospectively estimate the prevalence of mood and sexual side effects in combined oral contraceptives users to compare the severity of mood and sexual side effects between combined oral contraceptives users and placebo users
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att prospektivt beskriva förekomst av humör- och sexuella biverkningar vid användning av kombinerade p-piller att jämföra svårighetsgrad av humör- och sexuella biverkningar mellan kombinerade p-piller och placebo
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E.2.2 | Secondary objectives of the trial |
to investigate risk factors for these side-effects by taking previous psychiatric history, personality traits, baseline mood and genetic factors into account. |
att undersöka riskfaktorer för humörbiverkningar vid användning av kombinerade p-piller såsom tidigare psykiatrisk sjuklighet, personlighetsdrag, humörsymptom vid start av behandling samt ärftlighetsfaktorer
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18 -35 years Healthy according to self-report Informed consent Accept to use barrier contraception during the study or has cupper IUD or has been sterilized |
1. 18 – 35 år 2. Frisk enligt patientens uppfattning 3. Patientens eget samtycke till deltagande 4. Patienten accepterar att använda barriärmetod under studieperioden, eller har kopparspiral, eller är steriliserad
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E.4 | Principal exclusion criteria |
Current pregnancy or delivery within 6 months Systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg at screening BMI > 30 kg/m2 Prior history of venous thromboembolism or first degree relatives with history of venous thromboembolism Known predisposition for venous or arterial thromboembolism Prior or ongoing angina pectoris, TIA, myocardial infarction or stroke Myocardial infarction or stroke in first degree relatives Prior reproductive cancer (breast, uterus, cervical) Prior or ongoing pancreatitis Severe and ongoing liver disease or tumor. Migraine with aura Diabetes with known arterial disease Severe dyslipidemia Sensitivity to any of the active components of the investigated product |
1. Pågående graviditet eller förlossning < 6 månader sedan 2. Systoliskt blodtryck > 140 mmHg eller diastoliskt blodtryck > 90 mmHg vid screening 3. BMI > 30 kg/m2 4. Tidigare djup ventrombos, eller djup ventrombos hos förstagradssläkting 5. Ärftlig eller förvärvad predisposition för venös eller arteriell trombos som aktiverad protein C (APC)-resistens, antitrombin III-brist, protein C-brist, protein S-brist, hyperhomocysteinemi och antifosfolipid-antikroppar. 6. Tidigare eller pågående besvär med kärlkramp, TIA attack, hjärtinfarkt eller stroke 7. Hjärtinfarkt eller stroke hos förstagradssläkting (< 55 år hos pappa, < 65 år hos mamma) 8. Tidigare cancersjukdom som kan påverkas av könshormoner, t.ex. bröstcancer. 9. Tidigare eller pågående pankreatit om den är associerad med svår hypertriglyceridemi. 10. Svår, pågående leversjukdom eller levertumör 11. Migrän med fokala neurologiska symptom 12. Diabetes med kända kärlkomplikationer 13. Allvarlig dyslipoproteinemi 14. Överkänslighet mot de aktiva substanserna eller något hjälpämne i prövningsläkemedlet
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Summarized negative mood scores on the Daily Rating of Severity of Problem (DRSP) scale during treatment cycle three 2. McCoy female sexuality questionnaire (MFSQ) during treatment cycle three
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Summerade poäng på Daily Rating of Severity of Problem (DRSP) skalan Summerade poäng på McCoy female sexuality questionnaire (MFSQ) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pretreatment and during the last (third) treatment cycle |
Innan behandling samt under den sista (tredje) behandlingscykeln. |
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E.5.2 | Secondary end point(s) |
Number of women with clinically relevant worsening of mood or sexual function. |
Andelen kvinnor som försämras avseende humörsymptom och sexuella symptom. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pretreatment and during the last (third) treatment cycle |
Innan behandling samt under den sista (tredje) behandlingscykeln. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Adverse effects |
Biverkningar av behandling |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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LVLS |
Sista patientens sista besök |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |