Contraception MedDRA version: 12.1 Level: LLT Classification code 10030970 Term: Oral contraception
Conditions
Interventions
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 descriptiv
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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).;Primary end point(s): Mean daily delay of tablet release | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed