LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

PHASE3CompletedINTERVENTIONAL
Enrollment

567

Participants

Timeline

Start Date

January 6, 2011

Primary Completion Date

January 8, 2013

Study Completion Date

May 28, 2014

Conditions
Contraception
Interventions
DRUG

Levonorgestrel IUD (LCS, BAY86-5028)

LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.

DRUG

Yasmin (EE30/DRSP, BAY86-5131)

Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.

Trial Locations (94)

1070

Dr. Brigitte Wiesenthal, Vienna

Vienna

Hôpital Erasme/Erasmus Ziekenhuis, Bruxelles-brussel

Bruxelles-brussel

1200

Dr. Wolfgang Bartl, Vienna

Vienna

2018

Dr. Philip Loquet, Antwerp

Antwerp

2180

Gynaecologen Noord Antwerpen, Ekeren

Ekeren

2700

Dr. Max Stiglbauer, Wiener Neustadt

Wiener Neustadt

3000

UZ Leuven Gasthuisberg, Leuven

Leuven

3100

Ordination Dr. Schmidl-Amann, Sankt Pölten

Sankt Pölten

3430

Ordination Dr. Sator, Tulln

Tulln

6900

Landeskrankenhaus Bregenz, Bregenz

Bregenz

8010

Praxis Dr. Hannes Kahr, Graz

Graz

8570

Ordination Dr. Trost, Voitsberg

Voitsberg

8740

Dr. Walter Paulik, Zeltweg

Zeltweg

9000

UZ Gent, Ghent

Ghent

9020

Dr. Bernhard Svejda, Klagenfurt

Klagenfurt

19114

Clinical Research of Philadelphia, LLC, Philadelphia

Philadelphia

21073

Praxis Hr. Dr. D. Rautenberg, Hamburg

Hamburg

22159

Praxis Hr. Dr. K. Peters, Hamburg

Hamburg

22587

Praxis Hr. Dr. K. Buehling, Hamburg

Hamburg

30459

Praxis Hr. Dr. K. Greven, Hanover

Hanover

38889

Frauenarztpraxis Dr. Wetzel, Blankenburg

Blankenburg

39104

Praxis Fr. Dr. A. Braune, Magdeburg

Magdeburg

43213

Columbus Center for Women's Health Research, Columbus

Columbus

50931

Evangelisches Krankenhaus Köln Weyertal gGmbH, Cologne

Cologne

59590

Praxis Hr. Dr. E. Goeckeler-Leopold, Geseke

Geseke

68510

Women's Clinic of Lincoln, PC, Lincoln

Lincoln

76275

Praxis Hr. Dr. A. Soder, Ettlingen

Ettlingen

78414

Advanced Research Associates, Corpus Christi

Corpus Christi

85712

Visions Clinical Research - Tucson, Tucson

Tucson

91942

Grossmont Center for Clinical Research, La Mesa

La Mesa

92103

Genesis Center for Clinical Research, San Diego

San Diego

92108

Medical Center for Clinical Research, San Diego

San Diego

98105

Seattle Women's: Health, Research, Gynecology, Seattle

Seattle

153045

Instit. of Motherhood & Childhood care n.a. Gorodkov, Ivanovo

Ivanovo

199034

Institute of Obsteric & Gyn., Saint Petersburg

Saint Petersburg

630089

City Perinatal Center, Novosibirsk

Novosibirsk

656038

Altai State Medical University, Barnaul

Barnaul

664003

Scientific Center of family health & human reprod. problems, Irkutsk

Irkutsk

33472-2952

Visions Clinical Research, Boynton Beach

Boynton Beach

02118

Boston Medical Center, Boston

Boston

97239-3011

Oregon Health and Science University, Portland

Portland

01744

Frauenarztpraxis Dr. Robert Hantschel, Dippoldiswalde

Dippoldiswalde

01169

Praxis Hr. Dr. U. Kopprasch, Dresden

Dresden

04207

Frauenarztpraxis Dr. Bernd Pittner, Leipzig

Leipzig

04299

Praxis Fr. C. Burgkhardt, Leipzig

Leipzig

06406

Praxis f. Gynäkologie und Geburtshilfe, Bernburg

Bernburg

06917

Praxis Hr. H. Thelen, Jessen

Jessen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY