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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01331655

Enrollment

Registered

2011-04-08

Start date

2013-04-30

Completion date

2014-11-30

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGEE20/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

DRUGEE20/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

DRUGEE20/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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame
Number of bleeding days	Approximately 1 year

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026