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

• ClinicalTrials.gov Identifier: NCT01257984
• Recruitment Status: Completed
• First Posted: December 10, 2010
• Last Update Posted: October 28, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Contraception	Drug: BAY86-5300	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 508 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: December 2010
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

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
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 without reminder support

Outcome Measures

Primary Outcome Measures :

1. Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Number of delayed and missed pills [ Time Frame: 12 months ]
2. Bleeding pattern and cycle control parameters [ Time Frame: 12 months ]
3. Length of the tablet break and the length of the bleeding episode preceding the tablet break [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

  Hide Study Locations

Locations

France

Biarritz, France, 64200

Marly Le Roi, France, 78160

Nancy, France, 54000

Olivet, France, 45160

Paris, France, 75 009

Paris, France, 75 017

Paris, France, 75007

Paris, France, 75018

Strasbourg, France, 67 000

Toulouse, France, 31000

Germany

Heidelberg, Baden-Württemberg, Germany, 69115

Frankfurt, Hessen, Germany, 60590

Wuppertal, Nordrhein-Westfalen, Germany, 42103

Blankenburg, Sachsen-Anhalt, Germany, 38889

Burg, Sachsen-Anhalt, Germany, 39288

Magdeburg, Sachsen-Anhalt, Germany, 39130

Gera, Thüringen, Germany, 07545

Kahla, Thüringen, Germany, 07768

Hamburg, Germany, 20357

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

Elda, Alicante, Spain, 03600

Boadilla del Monte, Madrid, Spain, 28660

Barcelona, Spain, 08019

Córdoba, Spain, 14004

Málaga, Spain, 29013

United Kingdom

Chesterfield, Derbyshire, United Kingdom, S40 4TF

Nottingham, Nottinghamshire, United Kingdom, NG2 4PJ

Bath, Somerset, United Kingdom, BA1 2SR

East Horsley, Surrey, United Kingdom, KT24 6QT

Bradford-on-Avon, Wiltshire, United Kingdom, BA15 1DQ

Corsham, Wiltshire, United Kingdom, SN3 9DL

Cardiff, United Kingdom, CF5 4AD

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer Healthcare products.  Click here to find information about studies related to Bayer Healthcare products conducted in Europe 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01257984 History of Changes
• Other Study ID Numbers: 14701; 2010-019902-17 ( EudraCT Number )
• First Posted: December 10, 2010
• Last Update Posted: October 28, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Contraceptive Agents; Contraceptives, Oral; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Female