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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
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 |
Trial Design
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
Primary Outcome
- Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release timeTimeframe: 12 months
Secondary Outcome
- Number of delayed and missed pillsTimeframe: 12 months
- Bleeding pattern and cycle control parametersTimeframe: 12 months
- Length of the tablet break and the length of the bleeding episode preceding the tablet breakTimeframe: 12 months
Additional Information
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