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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01331655
• Other study ID #: 14700
• Status: Withdrawn
• Phase: Phase 3
• First received: April 7, 2011
• Last updated: July 14, 2014
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyMexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Contraception

Intervention

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
• 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
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding days		Approximately 1 year	No
Secondary	Difference in the number of missed tablets between Arms A and B		Approximately 1 year	No
Secondary	Bleeding pattern and cycle control parameters		Approximately 1 year	No
Secondary	Number of cycles per subject		Approximately 1 year	No

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