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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01331655

First received: April 7, 2011

Last updated: July 20, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 7, 2011

Last Updated Date

July 20, 2012

Start Date ^ICMJE

April 2013

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of bleeding days [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01331655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Difference in the number of missed tablets between Arms A and B [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
Bleeding pattern and cycle control parameters [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
Number of cycles per subject [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Contraception

Intervention ^ICMJE

Drug: EE20/DRSP (BAY86-5300)
Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP (1 tablet/day); up to 120-day treatment period followed by a 4-day tablet-free interval
Drug: EE20/DRSP/L-5-MTHF (BAY98-7071)
Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium (1 tablet/day) up to 120-day treatment period followed by a 4-day tablet-free interval
Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)
Day 1-24: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium per tablet (1 tablet/day) Day 25-28: tablets with 0.451 mg levomefolate calcium (1 tablet/day)

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: EE20/DRSP (BAY86-5300)
Experimental: Arm 2
Intervention: Drug: EE20/DRSP/L-5-MTHF (BAY98-7071)
Active Comparator: Arm 3
Intervention: Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

November 2014

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01331655

Other Study ID Numbers ^ICMJE

14700

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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