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

Sponsor

Bayer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01331655

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: EE20/DRSP (BAY86-5300) Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) Drug: EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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
Experimental: Arm 2	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
Active Comparator: Arm 3	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)

Arm

Intervention/Treatment

Experimental: Arm 1

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

Experimental: Arm 2

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

Active Comparator: Arm 3

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)

Outcome Measures

Primary Outcome Measures

Number of bleeding days [Approximately 1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT01331655

Other Study ID Numbers:

14700

First Posted:

Apr 8, 2011

Last Update Posted:

Jul 15, 2014

Last Verified:

Jul 1, 2014

Additional relevant MeSH terms:

Tetrahydrofolates

Drospirenone

Study Results

No Results Posted as of Jul 15, 2014