Trial Condition(s):

Contraception

Study to investigate compliance with the oral contraceptive SH T00186D in a flexible extended regimen supported by a dispenser with a reminder function

Bayer Identifier:

14701

ClinicalTrials.gov Identifier:

NCT01257984

EudraCT Number:

2010-019902-17

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
508
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69115

Status
Completed
 
Locations

Praxis Dr. A. Schwenkhagen-Stodieck

Hamburg, Germany, 20357

Status
Completed
 
Locations

Praxis Dr. S. Mucha & Dr. G. Schalk

Wuppertal, Germany, 42103

Status
Completed
 
Locations

Frauenarztpraxis Dipl. med. Michael Stellmacher

Burg, Germany, 39288

Status
Completed
 
Locations

Frauenarztpraxis Dr. med. Gabriele Weinreich

Magdeburg, Germany, 39130

Status
Completed
 
Locations

Frauenarztpraxis Dr. Wetzel

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Praxis Hr. Dr. R. Etzrodt

Gera, Germany, 07545

Status
Completed
 
Locations

Praxis Fr. Dr. A.Mönch-Hering

Kahla, Germany, 07768

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

A.O.U. di Cagliari

Cagliari, Italy, 09124

Status
Completed
 
Locations

A.O.U. di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

A.O.U. Policlinico - Vittorio Emanuele

Catania, Italy, 95123

Status
Completed
 
Locations

A.O.U. Policlinico Giaccone

Palermo, Italy, 90127

Status
Completed
 
Locations

A.O.U. Seconda Università

Napoli, Italy, 80138

Status
Terminated
 
Locations

IRCCS Fondazione Maugeri Clinica Lavoro e Riabilitazione

Pavia, Italy, 27100

Status
Completed
 
Locations

A.O. Spedali Civili

Brescia, Italy, 25123

Status
Completed
 
Locations

Centro de Atención Primaria Ramón Turró-PASSIR

Barcelona, Spain, 08019

Status
Completed
 
Locations

Centro de Salud Sexual y Reproductiva ELDA

Elda, Spain, 03600

Status
Completed
 
Locations

Centro de Orientación Sexual para Jóvenes. CS La Victoria

Málaga, Spain, 29013

Status
Completed
 
Locations

H.Universitario Madrid Montepríncipe

Boadilla del Monte, Spain, 28660

Status
Completed
 
Locations

Hospital Reina Sofía

Córdoba, Spain, 14004

Status
Completed
 
Locations

The Health Centre

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

Status
Completed
 
Locations

St James's Surgery

Bath, United Kingdom, BA1 2SR

Status
Completed
 
Locations

The Porch Surgery

Corsham, United Kingdom, SN3 9DL

Status
Completed
 
Locations

Ely Bridge Medical Centre

Cardiff, United Kingdom, CF5 4AD

Status
Completed
 
Locations

The Medical Centre

East Horsley, United Kingdom, KT24 6QT

Status
Completed
 
Locations

Greenwood and Sneinton Family Medical Centre

Nottingham, United Kingdom, NG2 4PJ

Status
Completed
 
Locations

Avondale Surgery

Chesterfield, United Kingdom, S40 4TF

Status
Completed
 
Locations

A.O. Sant'Andrea

Roma, Italy, 00189

Status
Completed
 
Locations

Cabinet Médical - Loiret - Olivet

OLIVET, France, 45160

Status
Completed
 
Locations

Cabinet Médical - Villersexel - Paris

PARIS, France, 75007

Status
Completed
 
Locations

Dr. Aliette Siboni-Frisch

Toulouse, France, 31000

Status
Completed
 
Locations

Cabinet gynecologie

BIARRITZ, France, 64200

Status
Completed
 
Locations

Dr Cecile Petrequin

Paris, France, 75018

Status
Completed
 
Locations

CM Ehret-Mentre

STRASBOURG, France, 67 000

Status
Completed
 
Locations

CM Labouz

STRASBOURG, France, 67 000

Status
Completed
 
Locations

CM Scheffler

NANCY, France, 54000

Status
Completed
 
Locations

CM Dagousset

PARIS, France, 75 017

Status
Terminated
 
Locations

CM Missey Kolb

MARLY LE ROI, France, 78160

Status
Completed
 
Locations

A.O. Istituti Clinici di Perfezionamento

Milano, Italy, 20154

Status
Completed
 
Locations

CM Lecocq

PARIS, France, 75 009

Status
Completed
 

Trial Design