Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function

Bayer

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: BAY86-5300

Study type

Interventional

Funder types

Industry

Identifiers

NCT01257984

14701

2010-019902-17 (EudraCT Number)

Details and patient eligibility

About

The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.

Enrollment

508 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

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