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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01331655
Other study ID # 14700
Secondary ID
Status Withdrawn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Status Withdrawn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


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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