- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00915174
Study to Evaluate the Effects of Neramexane on the Pharmacokinetics of a Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Healthy Female Subjects
5. maj 2011 opdateret af: Merz Pharmaceuticals GmbH
Primary:
To assess the effects of repeated dose of Neramexane on the steady-state pharmacokinetics of Drospirenone [DRSP] and Ethinyl Estradiol [EE]
Secondary:
To assess safety and tolerability of concomitant repeated dose treatments of Neramexane and a fixed-combinational DRSP- and EE-containing oral contraceptive [OC] (Yasmin®)
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Bavaria
-
Neu Ulm, Bavaria, Tyskland, 89231
- AAIharma Deutschland GmbH & Co. KG
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Healthy adult female subject of child bearing potential (including subject with tubal ligation), white origin, who is able to read, to write and fully understand German language
- Aged 18 to 45 years (both inclusive)
- BMI of 18-28 kg/m2 and a body weight of 50-90 kg (both inclusive)
- The subject is required
- To have taken a DRSP/EE- containing OC for at least two dosing cycles
- To agree using reliable non hormonal birth control methods from Day -1 of study Period 1 until the Final Examination (e.g. non-hormonal IUD, double barrier method [e.g. condom with spermicide or diaphragm with spermicide], sexual abstinence). Women with tubal ligation or sterilized partner do not need an additional birth control method
- Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study
Exclusion Criteria:
- History of clinically relevant allergy or known hypersensitivity to Neramexane/Memantine/ Amantadine and their derivatives
- Hypersensitivity to Quinine
- History of clinically relevant allergy or known hypersensitivity to any inactive ingredient in any of the used study medications (Neramexane, Yasmin®, Placebo) or tool substance
- History of clinically relevant allergy or known hypersensitivity to DRSP/EE
- Clinically relevant findings on the mammae or genital examination, PAP smear ≥ III
- Any contraindications against the oral contraceptive:
- present or past venous thromboses (deep vein thrombosis, pulmonary embolism);
- present or past arterial thromboses (e.g. myocardial infarction) or their prodromal stages (e.g. angina pectoris and transitory ischaemic attack);
- present or past cerebrovascular insult;
- presence of a serious risk factor or several risk factors for an arterial thrombosis: diabetes mellitus with vascular changes, severe hypertension, severe lipid metabolism disturbance;
- known or suspected genetic or acquired predisposition for venous or arterial thromboses like APC resistance,
- known or suspected genetic lack of antithrombin III, lack of protein C, lack of protein S, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulants);
- present or past pancreatitis if this is accompanied by severe hypertriglyceridaemia;
- present or past severe hepatic disease as long as the liver function tests have not normalized;
- severe renal insufficiency or acute renal failure;
- present or past hepatic tumors (benign or malign);
- known or suspected sexual hormone dependent, malign tumors (e.g. of the genital organs or the mamma);
- diagnostic not clarified vaginal bleedings;
- anamnesis of migraine with focal neurologic symptoms;
- known hereditary angioedema
- Exposure to another investigational agent within the last two months before Day 1 of Period 1
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area Under Curve within a dose interval (AUC, 0-tau) and Maximum Plasma Concentration at Steady State (Cmax) of Drospirenone (DRSP) and Ethinyl Estradiol (EE)
Tidsramme: 24 hours
|
24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2009
Primær færdiggørelse (Faktiske)
1. november 2009
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
4. juni 2009
Først indsendt, der opfyldte QC-kriterier
4. juni 2009
Først opslået (Skøn)
5. juni 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. maj 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2011
Sidst verificeret
1. maj 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- MRZ 92579/TI/1005
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .