E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We want to investigate if the pharmacocinetics of levonorgestrel differs in women who have had bariatric surgery compared to women who have not. Measures of serum concentrations of levonorgestrel will be made during 24 hours after intake of Neovletta, containing 0,15 mg levonorgestrel. |
Vi vill genomföra en undersökning av p-pillret Neovletta och titta på om serumkoncentrationen av levonorgestrel skiljer sig åt hos kvinnor som genomgått gastric bypass operation mot fetma jämfört med kvinnor som inte är opererade. Vi planerar mät serumkoncentrationen under ett dygn efter intag av en singeldos Neovletta som innehåller 0,15 mg levonorgestrel. |
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E.1.1.1 | Medical condition in easily understood language |
Normal weight women who have had bariatric surgery due to obesity. Can we recommend oral contraception? |
Kan vi rekommendera p-piller till kvinnor som genomgått 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 | 18.1 |
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 | 18.1 |
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. In Sweden 75% of the operated are women and most of them are still fertile. The operation reduces the volume of the ventricle and by passes a part of the small intestine, which leads to a lack of vitamins and minerals after surgery. How the operation affects the uptake of oral contraceptives is not well studied and we don´t know if these women can be recommended oral contraception. We seek to study if the serum concentration of levonorgestrel after intake of single dose Neovletta differs in women who have had gastric bypass in comparison to women who have not had the surgery. |
Som den i dagsläget främsta behandlingsmetoden mot uttalad fetma har antalet gastric bypass operationer i Sverige ökat sedan 10 år tillbaka. 75 % av de som opereras är kvinnor och medianålder är 41 år. Således är de stora flertalet av dessa kvinnor fortfarande fertila. De rekommenderas undvika graviditet det första året efter operationen. Idag är det oklart hur upptag och effektivitet av perorala preventivmedel påverkas av en gastric bypass operation. Vi planerar att genomföra en farmakokinetisk studie av p-pillret Neovletta. Syftet med studien är att analysera om serumkoncentrationen av levonorgestrel skiljer sig åt hos kvinnor som gjort gastric bypass jämfört med icke-opererade kvinnor. Mätningar kommer utföras efter intag av en singeldos Neovletta. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Ej aktullet |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Case: Swedish speaking women age 18-40. History of gastric bypass surgery > one year ago. BMI<30
Control: Swedish speaking women age 18-40 in the same BMI-class as "cases". |
Studiegrupp: Kvinna som genomgått gastric bypass för mer än ett år sedan. BMI<30. 18-40 år. Svensktalande. Frivilligt informerat samtycke. Kontrollgrupp: Kvinna som kan matchas med BMI (och om möjligt ålder) till studiedeltagare. 18-45 år. Svensktalande. Frivilligt informerat samtycke. |
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E.4 | Principal exclusion criteria |
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 blood sampling Lactose Intolerance Contraindication to Neovletta Daily smoking/intake of nicotine Use of medication as follows: 1. Intake of medicine or substance that is known to inhibit the activity of the enzymes CYP2C9, CYP2C19 and CYP3A4 (according to FDA´s interaction list Table 5) with exception of combined oral contraception for 7 days before clinical trial. 2. Intake of medicine or substance that is known to activate the activity of the enzymes CYP2C9, CYP2C19 and CYP3A4 (according to FDA´s interaction list Table 6) for four weeks before clinical trial. 3. Intake of medicine or substance which a clinical pharmacologist considers potential to interact with the metabolism of levonorgestrel. |
Bilateral ooforektomi. Graviditet/amning 3 mån före inklusion. Injektion av Depo-provera 12 mån före inklusion. Annan hormonell antikonception 4 veckor före provtagning. Diagnostiserad laktosintolerans. Kontraindikation mot Neovletta®. Daglig rökning/snusning/nikotinintag. Deltagande i annan klinisk läkemedelsprövning. Pågående medicinering enl följande: 1. Intag av läkemedel eller substans som kan hämma aktiviteten i enzymerna CYP2C9, CYP2C19 och CYP3A4 (enligt FDAs interaktionslistor Table 5) med undantag för p-piller under 7-dagarsperioden innan provtagning. 2. Intag av läkemedel eller substans som kan inducera aktiviteten i enzymerna CYP2C9, CYP2C19 och CYP3A4 (enligt FDAs interaktionslistor Table 6) under 4-veckorsperioden innan provtagning. 3. Intag av substans eller läkemedel som klinisk farmakolog bedömer kan interagera med levonorgestrels metabolism. Kan till exempel vara annat prövningsläkemedel, läkemedel i depotform).
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E.5 End points |
E.5.1 | Primary end point(s) |
Maximal serumkoncentration and 24-hour AUC (area under the curve) of levonorgestrel |
Maximal serumkoncentration och 24 timmars AUC (area under the curve) för levonorgestrel |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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 aktellt |
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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 | No |
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
| 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 | 2 |
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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Last phone call to the last subject |
sista telefonsamtalet 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |