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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01257984
Other study ID # 14701
Secondary ID 2010-019902-17
Status Completed
Phase Phase 3
First received December 9, 2010
Last updated October 27, 2014
Start date December 2010
Est. completion date September 2012

Study information

Verified date October 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.


Recruitment information / eligibility

Status Completed
Enrollment 508
Est. completion date September 2012
Est. primary completion date August 2012
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 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

- Severe renal insufficiency or acute renal failure

- History of migraine with focal neurologic symptoms

- Epilepsy

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
BAY86-5300
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function
BAY86-5300
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser without reminder support

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time 12 months No
Secondary Number of delayed and missed pills 12 months No
Secondary Bleeding pattern and cycle control parameters 12 months No
Secondary Length of the tablet break and the length of the bleeding episode preceding the tablet break 12 months No
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