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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
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Trial Design
A multicenter, open-label, 3-arm, active-controlled, parallel-group, 1-year study to investigate the efficacy and safety of a flexible regimen of the combined oral contraceptive, with and without 0.451 mg levomefolate calcium (BAY98-7071 and BAY86-5300, respectively) versus the standard 24 + 4 regimen with levomefolate (BAY98-7071 + BAY86-7660) and to assess compliance with a device (CADDY) in healthy women who desire contraception
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Number of bleeding daysTimeframe: Approximately 1 year
Secondary Outcome
- Difference in the number of missed tablets between Arms A and BTimeframe: Approximately 1 year
- Bleeding pattern and cycle control parametersTimeframe: Approximately 1 year
- Number of cycles per subjectTimeframe: Approximately 1 year
Additional Information
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