Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function

A Multicenter, Open-label, Randomized, Controlled, Two-arm Study to Assess Compliance With Daily Tablet Intake of Women on Treatment With the Oral Contraceptive SH T00186D/BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function Over 12 Months

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: BAY86-5300; Drug: BAY86-5300

• Study Type: Interventional
• Enrollment (Actual): 508
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Biarritz, France, 64200
  • Marly Le Roi, France, 78160
  • Nancy, France, 54000
  • Olivet, France, 45160
  • Paris, France, 75018
  • Paris, France, 75007
  • Paris, France, 75 009
  • Paris, France, 75 017
  • Strasbourg, France, 67 000
  • Toulouse, France, 31000
• Germany
  • Hamburg, Germany, 20357
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69115
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
  • Nordrhein-Westfalen
    • Wuppertal, Nordrhein-Westfalen, Germany, 42103
  • Sachsen-Anhalt
    • Blankenburg, Sachsen-Anhalt, Germany, 38889
    • Burg, Sachsen-Anhalt, Germany, 39288
    • Magdeburg, Sachsen-Anhalt, Germany, 39130
  • Thüringen
    • Gera, Thüringen, Germany, 07545
    • Kahla, Thüringen, Germany, 07768
• Italy
  • Bologna, Italy, 40138
  • Brescia, Italy, 25123
  • Cagliari, Italy, 09124
  • Catania, Italy, 95123
  • Milano, Italy, 20154
  • Modena, Italy, 41124
  • Napoli, Italy, 80138
  • Palermo, Italy, 90127
  • Pavia, Italy, 27100
  • Pisa, Italy, 56126
  • Roma, Italy, 00189
  • Siena, Italy, 53100
• Spain
  • Barcelona, Spain, 08019
  • Córdoba, Spain, 14004
  • Málaga, Spain, 29013
  • Alicante
    • Elda, Alicante, Spain, 03600
  • Madrid
    • Boadilla del Monte, Madrid, Spain, 28660
• United Kingdom
  • Cardiff, United Kingdom, CF5 4AD
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom, S40 4TF
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG2 4PJ
  • Somerset
    • Bath, Somerset, United Kingdom, BA1 2SR
  • Surrey
    • East Horsley, Surrey, United Kingdom, KT24 6QT
  • Wiltshire
    • Bradford-on-Avon, Wiltshire, United Kingdom, BA15 1DQ
    • Corsham, Wiltshire, United Kingdom, SN3 9DL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	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; 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 without reminder support
Experimental: Arm 2	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; 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 without reminder support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of delayed and missed pills	12 months
Bleeding pattern and cycle control parameters	12 months
Length of the tablet break and the length of the bleeding episode preceding the tablet break	12 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimate): December 10, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 14701 (Other Identifier: Other); 2010-019902-17 (EudraCT Number)