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

• Register: EUCTR
• Last refreshed on: 25 September 2012
• Main ID: EUCTR2010-019902-17-GB
• Date of registration: 26/10/2010
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: investigation of the effect of the CADDY dispenser's buzzer function on the compliance of women taking YAZ Flex using a flexible dose schedule
• Scientific title: 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: 17/12/2010
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019902-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: two treatment arms If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Arm B - Group with inactivated CADDY buzzer Number of treatment arms in the trial: 2

Countries of recruitment

Germany, Italy, Spain, United Kingdom

Contacts

• Name: CTP Team/ REF. 'EU CTR'/S102- R
• Affiliation: Bayer HealthCare AG

• Name: CTP Team/ REF. 'EU CTR'/S102- R
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Contraception
MedDRA version: 14.0 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures

Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Intervention(s)

Trade Name: Yaz®
Product Name: DRSP+EE tablets 3 mg + 20 µg
Product Code: SH T00186D/BAY 86-5300
Pharmaceutical Form: Tablet
INN or Proposed INN: Drospirenone
CAS Number: 67392-87-4
Other descriptive name: DROSPIRENONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Other descriptive name: ETHINYLESTRADIOL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.02-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Daily for 12 months

Primary end point(s): Mean daily delay of tablet release

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).

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.

Secondary Outcome(s)

Secondary end point(s): 1. Number of delayed and missed tablets,
2. bleeding pattern
3. cycle control parameters

Timepoint(s) of evaluation of this end point: Daily or as specified in patient diary

Secondary ID(s)

BAY86-5300/14701

2010-019902-17-DE

Source(s) of Monetary Support

Bayer HealthCare AG