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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 2 October 2017
Main ID:  EUCTR2011-000989-35-FR
Date of registration: 06/05/2011
Prospective Registration: Yes
Primary sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Public title: N/A
Scientific title: N/A - RESPIRONDINE
Date of first enrolment:
Target sample size:
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000989-35
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
France
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
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Key inclusion & exclusion criteria
Inclusion criteria:
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
Health Condition(s) or Problem(s) studied

MedDRA version: 14.0 Level: PT Classification code 10066131 Term: Congenital central hypoventilation syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Intervention(s)

Trade Name: Cerazette
Product Name: Cerazette
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: D├ęsogestrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.075-

Primary Outcome(s)
Main Objective:
Primary end point(s):
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
NCT01243697
P101001
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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