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Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Child Bearing Potential and Birth Control

- 17-01-19 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Child-Bearing Potential, Birth Control Methods
Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders This document asks if the subject is of child-bearing potential and which birth control methods the subject is using to prevent pregnancy during the study. This form should be filled out for female subjects at the screening visit.

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Childbearing Potential, Birth Control Methods and Medical Conditions

- 09-11-18 - 1 Formulier, 4 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Child-bearing Potential (Complete for Female Subjects Only), Birth Control Methods, Medical Conditions
This ODM-file contains the form to document the childbearing potential, birth control methods and medical conditions of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Contraceptive Methods - Female PhenX Toolkit

- 26-04-16 - 1 Formulier, 1 Itemgroep, 18 Data-elementen, 1 Taal
Itemgroep: PhenX - contraceptive methods - female protocol
Female participants are asked whether they have had a tubal ligation and whether they are able to have children. They are also asked about whether their male partners can have children. Female participants are then asked about the type of birth control they have used in the past and the type they are currently using. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

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