E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We want to investigate how the pharmacocinetics changes for Cerazette in 14 fertile obese women after, compared to before, bariatric surgery in forms of gastric by pass. Mesures of serum concetrations of desogestrel (the active metabolite of Cerazette) will be made in the same women 3 months before and 3 and 12 months after surgery. The women selected for the trial will all ready be users of Cerazette.
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Vi vill genomföra en undersökning p-pillret Cerazette och titta på serumkoncentrationen av desogestrel (aktiv metabolit till Cerazette) hos kvinnor som genomgår fetmakirurgi, gastric by pass. Mätningar kommer göras hos 14 kvinnor, före de blir opererade samt 3 mån och 12 månader efter operationen. Förändras farmakokinetiken av Cerazette, sjunker nivåerna av Cerazettes aktiva metabolit desogestrel efter operationen? |
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E.1.1.1 | Medical condition in easily understood language |
Fourteen obese women undergoing bariatric surgery for obesitas. |
Fertila kvinnor som genomgår kirurgi mot fetma |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061966 |
E.1.2 | Term | Gastric bypass |
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 |
Gastric bypass is increasing all over the world as one of the most effective treatments of obesity, even so in Sweden. Here 75% of the operated are women and most of them are still fertile. They are recommended not to become pregnant for at least 12 months after surgery.
The operation reduces the volume of the ventricle and by passes a part of the small intestine, wich leads to a lack of vitamins and minerals after surgery.
How the operation affects the uptake of oral contraceptives are not studied and we don´t know if these women can be recommended oral contraceptives after surgery. We seek to study the changes in maximal serum concentration of the actvie metabolite of the progestine only pill, Cerazette 3 months before, 3 months after and 12 months after surgery. |
Som den i dagsläget främsta behandlingsmetoden mot uttalad fetma ökar antalet gastric by pass operationer dramatisk i Sverige. 75 % av de som opereras i Sverige är kvinnor. Medianåldern är 41 år. Kvinnor avrådes från att bli gravida 12mån efter operationen.
I dag är det oklart hur upptag och effektivitet av perorala preventivmedel påverkas av en gastric bypass operation.
Då den tromboemboliska risken hos feta är ökad avråds dessa kvinnor från användning av kombinerade p-piller. Det mest intressanta preparatet att undersöka blir härav ett renodlat gestagenpreparat, Cerazette, innhållande 75µg desogestrel.
Vi planerar genomföra en farmakokinetisk studie av detta preparat.
Syftet med studien är att analysera om serumkoncentrationerna av etonogestrel (aktiv metabolit av desogestrel) efter intag av Cerazette (75µg desogestrel) påverkas efter en genomgången gastric bypass.
Analyser planeras att göras ca 3 mån före och 3 mån resp 12 månader efter operationen.
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E.2.2 | Secondary objectives of the trial |
not applicable |
ej aktuellt |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women age 18- 45
Accepted to undergo gastric bypass
All ready using Cerazette
Speaks Swedish fluently |
Kvinna, 18-45 år
Accepterad för gastric bypass
Använder Cerazette
Svensktalande |
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E.4 | Principal exclusion criteria |
Prior hysterectomy
Prior bilateral ooforectomy
Pregnancy and or lactation three months before inclusion
Use of Depo-provera twelve months before inclusion
Other hormonal contraception four weeks before inclusion
Undiagnosed vaginal bleeding
Low calorie diet
Use of anti epileptic drugs, use of rifampicin, use of St John´s wort
Lactose intolerance
Contraindication to Cerazette
Smoking |
Hysterektomi
Ooforektomi bilateralt
Graviditet/amning 3 mån före inklusion
Depo-provera 12 mån före inklusion
Annan hormonell antikonception 4 veckor före inklusion
Oklara vaginala blödningar
Lågkaloridiet
Användning av antiepileptika, rifampicin, johannesört
Laktosintolerans
Kontraindikation mot Cerazette
Rökning
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E.5 End points |
E.5.1 | Primary end point(s) |
Does gastric bypass surgery affect the serum concentration of etonogestrel measured as maximal plasma concentration (Area Under the Curve - AUC)? |
Påverkar gastric bypass operation serumkoncentrationen av etonogestrel mätt såsom maximal plasmakoncentration (Area Under the Curve - AUC)? |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After all the measurements of all the participants have been made |
När alla provtagningar är utförda på alla studiedeltagare. |
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E.5.2 | Secondary end point(s) |
not applicable |
ej aktuellt |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Ej aktuellt |
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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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Prospektiv studie med farmakokinetisk mätning hos patienter innan och efter fetmakirurgi |
Prospectice study. with pharmacocinetical measurements before and after bariatrisc study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 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 besöket för sista studiedeltagaren |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |