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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:
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EUCTR |
Last refreshed on:
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25 September 2012 |
Main ID: |
EUCTR2010-019902-17-IT |
Date of registration:
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03/11/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Scientific title:
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A multicenter, open-label, randomized, controlled, two-arm study to assess compliance with daily tablet intake of women on treatment with the oral contraceptive SH T00186D/BAY 86-5300 (0.02 mg ethinyl estradiol as betadex clathrate and 3 mg drospirenone) in a flexible extended regimen supported by a dispenser (CADDY) with a reminder function over 12 months - EU-Compliance by buzzer study of YAZ Flex in the CADDY |
Date of first enrolment:
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25/11/2010 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019902-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Germany
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Italy
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Spain
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United Kingdom
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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 subjects requesting contraception 3) Age between 18 and 35 years (inclusive), smokers must not be older than 30 years at the time point of informed consent 4) Normal or clinically insignificant 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). Subjects with ASCUS can be included if they are negative for high-risk HPV strains. (HPV testing in subjects with ASCUS will be used as an adjunctive test). 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 (less than 3 months since delivery, abortion, or lactation before start of treatment) - Body mass index (BMI) >=30.0 kg/m2 - Presence or a history of venous or arterial thrombotic/thromboembolic events - Repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg. - Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use - Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement - Severe dyslipoproteinemia - Malignant or premalignant disease - Uncontrolled thyroid disorder - Chronic inflammatory bowel disease - Severe renal insufficiency or acute renal failure - History of migraine with focal neurologic symptoms - Epilepsy
Age minimum:
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Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Contraception MedDRA version: 9.1
Level: PT
Classification code 10030970
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Intervention(s)
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Trade Name: YAZ Pharmaceutical Form: Tablet INN or Proposed INN: ETINILESTRADIOLO CAS Number: 57-63-6 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 20- INN or Proposed INN: DROSPIRENONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: In addition, the efficacy and safety of the oral contraceptive SH T00186D/BAY 86-5300 (0.02 mg EE as betadex clathrate [beta-CDC] and 3 mg DRSP) will be evaluated in a flexible extended regimen administered using a compliance-aiding dispenser (CADDY).
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Main Objective: The objective of the study is to evaluate the effect of the dispenser’s buzzer function on compliance with daily tablet intake when administered for approximately 12 months to healthy female volunteers between 18 and 45 years of age (inclusive), who request contraception; smokers must not be older than 35 years at the time point of informed consent
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Primary end point(s): Mean daily delay of tablet release
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Secondary ID(s)
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BAY 86-5300/14701
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2010-019902-17-DE
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Source(s) of Monetary Support
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Results
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Results available:
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