ID
34026
Description
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 by female subjects at the screening visit.
Keywords
Versions (3)
- 1/11/19 1/11/19 -
- 1/13/19 1/13/19 -
- 1/17/19 1/17/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 11, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Study Name: Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998
Child Bearing Potential and Birth Control
- StudyEvent: ODM
Description
Child-Bearing Potential
Alias
- UMLS CUI-1
- C3831118
Description
Birth Control Methods
Alias
- UMLS CUI-1
- C0700589
Description
Oral contraceptive
Data type
boolean
Alias
- UMLS CUI [1]
- C0009905
Description
Intrauterine contraceptive device
Data type
boolean
Alias
- UMLS CUI [1]
- C0021900
Description
Depot contraceptive (implants, injectables)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0086129
Description
Spermicide plus physical barrier
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0037862
- UMLS CUI [1,2]
- C0004764
Description
Barrier method only if used in combination with any of the other acceptable contraception methods.
Data type
boolean
Alias
- UMLS CUI [1]
- C0004764
- UMLS CUI [2]
- C0042241
- UMLS CUI [3]
- C3873750
Description
Abstinence
Data type
boolean
Alias
- UMLS CUI [1]
- C3843422
Description
Sterilization of male partner
Data type
boolean
Alias
- UMLS CUI [1]
- C0024559
Description
Other
Data type
boolean
Alias
- UMLS CUI [1]
- C0205394
Description
Other Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Similar models
Child Bearing Potential and Birth Control
- StudyEvent: ODM
C0086129 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,2])
C0042241 (UMLS CUI [2])
C3873750 (UMLS CUI [3])
C2348235 (UMLS CUI [1,2])
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