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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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25 November 2019 |
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Main ID: |
EUCTR2008-004214-27-FR |
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Date of registration:
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14/11/2008 |
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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, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects - EU/LA/AUS Pearl Index study – transdermal contraceptive patch
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Scientific title:
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Multi-center, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects - EU/LA/AUS Pearl Index study – transdermal contraceptive patch |
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Date of first enrolment:
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29/04/2009 |
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Target sample size:
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1650 |
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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:2008-004214-27 |
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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: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Germany
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Italy
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Spain
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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 female subject 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:
1. Pregnancy or lactation (less than 3 menstrual cycles before start of treatment)
2. Obesity (Body Mass Index > 30.0 kg/m2)
3. Hypersensitivity to any ingredient of the study drug
4. Significant skin reaction to transdermal preparations or sensitivity to surgical/
medical tape
5. Any diseases or conditions that can compromise the function of the body systems
and could result in altered absorption, excessive accumulation, impaired
metabolism, or altered excretion of the study drug (e.g., known skin disease with
suspected alteration of dermal absorption or poor adherence of the patch such as
psoriasis)
6. Any diseases or conditions that might interfere with the conduct of the study or
the interpretation of the results
7. Any disease or condition that may worsen under hormonal treatment such as:
Cardiovascular
- presence or a history of venous or arterial thrombotic/thromboembolic events
(e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of
a cerebrovascular accident, including prodromi (e.g., transient ischaemic attack,
angina pectoris) and conditions that could increase the risk to suffer from any of
the above mentioned disorders, e.g., a family history indicating a hereditary
predisposition
- repeated measurements of systolic blood pressure > 140 mm Hg and/or diastolic
blood pressure > 90 mm Hg
Liver
- presence or history of liver tumors (benign or malignant)
- presence or history of severe hepatic disease as long as liver function values
have not returned to normal
- jaundice and/or pruritus related to cholestasis (Gilbert’s syndrome excepted)
- history of cholestatic jaundice associated with pregnancy or previous COC use
Metabolic diseases
- uncontrolled diabetes mellitus and/or diabetes mellitus with vascular
involvement
- severe dyslipoproteinemia
Other diseases
- malignant or premalignant disease
- uncontrolled thyroid disorder
- severe renal insufficiency or acute renal failure
- history of hypertriglyceridemia-associated pancreatitis
- pemphigoid gestationis during a previous pregnancy
- history of herpes gestationis
- otosclerosis-related hearing loss
- history of migraine with focal neurologic symptoms
- epilepsy
- clinically significant depression
- hereditary angioedema
8. Undiagnosed abnormal genital bleeding
9. Abuse of alcohol, drugs, or medicines (e.g., laxatives)
10. Other contraceptive methods:
- sterilization
- oral, vaginal, or transdermal hormonal contraception during treatment
- intrauterine devices (IUDs) with or without hormone release
- implants
- long-acting preparations (e.g., Depot-MPA, monthly contraceptive injection)
within a period of 3 times of the injection interval before start of treatment.
11. Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results such as:
- products containing St. John’s wort (Hypericum perforatum)
- antibiotics (except for short-term treatment)
- anticoagulants (e.g., heparin, coumarin)
- antiepileptics (hydantoin derivatives [e.g., phenytoin] or carboxamide derivatives
[e.g., carbamazepine, oxcarbamazepine], others [e.g., felbamate, topiramate])
- hypnotics and sedati
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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The primary objective of this study is to investigate the contraceptive efficacy of the transdermal contraceptive patch (material no. 80876395).
MedDRA version: 9.1
Level: PT
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-
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to investigate the contraceptive efficacy of the transdermal contraceptive patch (material no. 80876395).
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Secondary Objective: The secondary objectives are bleeding pattern, cycle control and safety profile. Compliance and subjective assessment of satisfaction with the transdermal contraceptive patch will also be evaluated as secondary objectives.
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Primary end point(s): The primary efficacy variable is the occurrence of pregnancy (yes/no) while on treatment up to 7 days after removal of the last patch, assessed by the Pearl Index and life table analysis.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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