Status:
COMPLETED
Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
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 contra...
Eligibility Criteria
Inclusion
- Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT01257984
Start Date
December 1 2010
End Date
September 1 2012
Last Update
October 28 2014
Active Locations (43)
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1
Paris, Paris, France, 75018
2
Biarritz, France, 64200
3
Marly-le-Roi, France, 78160
4
Nancy, France, 54000