Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America

Phase 3

Withdrawn

• Conditions: Contraception
• Interventions: Drug: EE20/DRSP (BAY86-5300); Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660); Drug: EE20/DRSP/L-5-MTHF (BAY98-7071)

• Registration Number: NCT01331655
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Study Start: 2013-04
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	EE20/DRSP (BAY86-5300)	-
Arm 3	EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)	-
Arm 2	EE20/DRSP/L-5-MTHF (BAY98-7071)	-

Primary Outcome Measures

Name	Time	Method
Number of bleeding days	Approximately 1 year

Secondary Outcome Measures

Name	Time	Method
Bleeding pattern and cycle control parameters	Approximately 1 year
Number of cycles per subject	Approximately 1 year
Difference in the number of missed tablets between Arms A and B	Approximately 1 year