Trial Condition(s):
Study to investigate compliance with the oral contraceptive SH T00186D in a flexible extended regimen supported by a dispenser with a reminder function
14701
Not Available
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.
- Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection
- 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
Locations | Status | |
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Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. A. Schwenkhagen-Stodieck Hamburg, Germany, 20357 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Mucha & Dr. G. Schalk Wuppertal, Germany, 42103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dipl. med. Michael Stellmacher Burg, Germany, 39288 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. med. Gabriele Weinreich Magdeburg, Germany, 39130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Wetzel Blankenburg, Germany, 38889 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. R. Etzrodt Gera, Germany, 07545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. A.Mönch-Hering Kahla, Germany, 07768 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Cagliari Cagliari, Italy, 09124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna - Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Modena Policlinico Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico - Vittorio Emanuele Catania, Italy, 95123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Giaccone Palermo, Italy, 90127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Seconda Università Napoli, Italy, 80138 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Maugeri Clinica Lavoro e Riabilitazione Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Atención Primaria Ramón Turró-PASSIR Barcelona, Spain, 08019 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Sexual y Reproductiva ELDA Elda, Spain, 03600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Orientación Sexual para Jóvenes. CS La Victoria Málaga, Spain, 29013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H.Universitario Madrid Montepríncipe Boadilla del Monte, Spain, 28660 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Health Centre Bradford-on-Avon, United Kingdom, BA15 1DQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St James's Surgery Bath, United Kingdom, BA1 2SR | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Porch Surgery Corsham, United Kingdom, SN3 9DL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ely Bridge Medical Centre Cardiff, United Kingdom, CF5 4AD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medical Centre East Horsley, United Kingdom, KT24 6QT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Greenwood and Sneinton Family Medical Centre Nottingham, United Kingdom, NG2 4PJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Avondale Surgery Chesterfield, United Kingdom, S40 4TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sant'Andrea Roma, Italy, 00189 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Loiret - Olivet OLIVET, France, 45160 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Villersexel - Paris PARIS, France, 75007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Aliette Siboni-Frisch Toulouse, France, 31000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet gynecologie BIARRITZ, France, 64200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Cecile Petrequin Paris, France, 75018 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CM Ehret-Mentre STRASBOURG, France, 67 000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CM Labouz STRASBOURG, France, 67 000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CM Scheffler NANCY, France, 54000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CM Dagousset PARIS, France, 75 017 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CM Missey Kolb MARLY LE ROI, France, 78160 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Istituti Clinici di Perfezionamento Milano, Italy, 20154 | Status Completed | Contact Us: E-mail: clinical-tri[email protected] Phone: Not Available |
Locations CM Lecocq PARIS, France, 75 009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
2