investigation of the effect of the CADDY dispenser's buzzer function on the compliance of women taking YAZ Flex using a flexible dose schedule

• Conditions: Contraception; MedDRA version: 14.0Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2010-019902-17-GB
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-26
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 500

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 500
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified