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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-007308-27-NL |
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Date of registration:
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04/02/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 women - Transdermal contraceptive patch: EU cycle control study (vs. EVRA)
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Scientific title:
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Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 women - Transdermal contraceptive patch: EU cycle control study (vs. EVRA) |
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Date of first enrolment:
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23/06/2009 |
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Target sample size:
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400 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007308-27 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Czech Republic
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1.Signed and dated informed consent
2.Healthy woman requesting contraception
3.Age: 18 – 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
4.Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
5.History of regular cyclic menstrual periods
Are the trial subjects under 18? no
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:
Pregnancy or lactation, obesity (BMI > 30), hypersensitivity to any ingredient of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/ accumulation/ metabolism/ excretion of the study drug), any diseases/ conditions that may worsen under hormonal treatment.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Prevention of pregnancy
MedDRA version: 9.1
Level: LLT
Classification code 10060346
Term: Transdermal contraception
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Intervention(s)
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Product Name: FC Patch Low
Product Code: material no. 80876395
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Ethinylestradiol
CAS Number: 57-63-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.55-
INN or Proposed INN: Gestodene
CAS Number: 60282873
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.1-
Trade Name: EVRA
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Ethinylestradiol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-
INN or Proposed INN: Norelgestomin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
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Primary Outcome(s)
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Primary end point(s): Cycle control parameters and bleeding pattern indices
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Main Objective: The primary objective is to investigate the bleeding pattern and cycle control parameters of the transdermal contraceptive patch FC Patch Low (material no. 80876395 containing 0.55 mg EE and 2.1 mg GSD) in comparison to the EVRA patch (containing 0.6 mg EE and 6 mg NGMN).
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Secondary Objective: The secondary objectives are the contraceptive efficacy, safety profile (including lipid/carbohydrate metabolism), and population pharmacokinetics of FC Patch Low in comparison to the EVRA patch.
Additionally, compliance and subjective assessment of the treatment will be evaluated as secondary objectives.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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