Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2004-001613-34 | |||
| 304004 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027, SH T00658K) | Drug | 7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding pattern | 7 treatment cycles each consisting of 28 days | |
| Number of unintended pregnancies | 7 treatment cycles each consisting of 28 days and follow-up period of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event collection | 7 treatment cycles each consisting of 28 days and follow-up period of 14 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soukroma gynekologicka ambulance | Fulnek | 74245 | Czechia | |||
| Soukroma gynekologicka ambulance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19835717 | Derived | Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SH D 593 B (Miranova) | Drug | 7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo |
|
| Pilsen |
| 30708 |
| Czechia |
| Provozorna Gynekologicka ordinace Dr. Tesar | Prague | 109 00 | Czechia |
| Femina Sana s.r.o | Prague | 13000 | Czechia |
| Soukroma gynekologicka ambulance | Zábřeh nad Odrou | 70400 | Czechia |
| Dr. Jocelyne Nataf-Maurin | Brignoles | 83170 | France |
| Dr. Marie-Helene Malbranche-Aupecle | Dijon | 21000 | France |
| Centre Hospitalier de l Estuaire | Honfleur | 14601 | France |
| Dr. Annette Mercier | Morlaix | 29600 | France |
| Clinique d Occitanie | Muret | 31600 | France |
| Centre Medical du Val de Loire | Nevers | 58000 | France |
| Dr. Anne-Isabelle Richet | Paris | 75007 | France |
| Cabinet medical | Quetigny | 21800 | France |
| Dr. Gwendoline Servan | Tarare | 69170 | France |
| Dr. Aliette Siboni-Frisch | Toulouse | 31000 | France |
| Frauenarztpraxis Dr. Buchberger | Neubiberg | Bavaria | 85579 | Germany |
| Praxis Hr. Dr. R. Kuett | Nuremberg | Bavaria | 90491 | Germany |
| Praxis Dr. Larbig | Fulda | Hesse | 36037 | Germany |
| Praxis Fr. Dr. J. Schmidt-Pich | Hanover | Lower Saxony | 30159 | Germany |
| Praxis Fr. Dr. A. Münzberger | Döbeln | Saxony | 04720 | Germany |
| Praxis Fr. Dr. K. Kopprasch | Dresden | Saxony | 01169 | Germany |
| Praxis Fr. R. Hellmich | Dresden | Saxony | 01187 | Germany |
| Frauenarztpraxis Dr. Bernd Pittner | Leipzig | Saxony | 04207 | Germany |
| Praxis Fr. Dr. C. Burgkhardt | Leipzig | Saxony | 04299 | Germany |
| Frauenarztpraxis Dr. Wetzel | Blankenburg | Saxony-Anhalt | 38889 | Germany |
| Frauenarztpraxis Dipl. med. Michael Stellmacher | Burg | Saxony-Anhalt | 39288 | Germany |
| Praxis Fr. Dr. A. Braune | Magdeburg | Saxony-Anhalt | 39104 | Germany |
| Praxis Hr. Prof. Dr. H.-J. Ahrendt | Magdeburg | Saxony-Anhalt | 39126 | Germany |
| Frauenarztpraxis Hr. Dr. H. Lindecke | Berlin | State of Berlin | 10247 | Germany |
| Praxis Fr. Dr. B. Heuberger | Berlin | State of Berlin | 12587 | Germany |
| Praxis Hr. Dr. Karl-Heinz Belling | Berlin | State of Berlin | 13086 | Germany |
| Frauenarztpraxis Hr. Dr. B. Hamann | Berlin | State of Berlin | 13187 | Germany |
| Praxis Hr. R. Wähnert | Gera | Thuringia | 07545 | Germany |
| Praxis Fr. Dr. A.Mönch-Hering | Kahla | Thuringia | 07768 | Germany |