Trial Condition(s):

Contraception

Clinical study of a conventional and flexible extended oral contraceptive of EE/DRSP with or without Metafolin in Latin America

Bayer Identifier:

14700

ClinicalTrials.gov Identifier:

NCT01331655

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.

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 combined oral contraceptive (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

Trial Summary

Enrollment Goal
0
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
BEYAZ (EE20/DRSP/L-5-MTHF, BAY98-7071)
Accepts Healthy Volunteers
Yes

Where to Participate

Locations
Status
LocationsStatus

Trial Design