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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005258-22 | EudraCT Number | ||
| 311926 | Other Identifier | Company Internal |
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The study will be performed as a multi-center, randomized, double-blind, parallel-group trial in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be randomized into one of the six treatment groups. The study will be performed only in Germany. The investigational drug is an oral contraceptive. It contains the estrogen estradiol (E2) and the progestogen drospirenone (DRSP). As the contraceptive efficacy has not yet been proven for these new regimens, even a protection against unwanted pregnancies cannot be assured. The treatments will be applied daily for 7 cycles of 28 days each without pill-free interval, i.e., for 196 consecutive days. Treatment will be initiated after a screening period of approximately 1 to 2 weeks, the latter focused on confirmation of the baseline safety status. Tablet intake will start on the first day of the first menstrual/withdrawal bleeding after Visit 2, regardless of whether the volunteer is a first user (starter) or switching from another COC. In the following cycles, tablet intake is not to be triggered by any bleeding events. The primary objective of this study is to evaluate and compare the cycle control and bleeding patterns of six different treatment regimens with E2/DRSP during administration for 7 treatment cycles. Volunteers will be provided with a diary to document the intake of study medication, any bleeding events, and days without bleeding, pregnancy test results. Safety will be also assessed. During the whole study period, 4 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breast palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.Additional examinations can be performed any time, if this becomes necessary for medical reasons. At Visit 3 or in case of premature discontinuation of study the investigator will discuss options for follow-up contraception with the volunteer. The volunteer can start the intake of a post-treatment OC on the day after the last tablet intake of study medication, after a negative urine ß-HCG test (home pregnancy test) result.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for one day and placebo for three days in a 28 day cycle |
|
| Arm 2 | Experimental | E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for two days and placebo for two days in a 28 day cycle |
|
| Arm 3 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, and placebo for days 25-28 in a 28 day cycle |
|
| Arm 4 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 1 (SHT04984F) for one day in a 28 day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2/DRSP (BAY 86-4891) dose 1 (SH T04984E) | Drug | Single dose administration of E2 + DRSP as a tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of intracyclic bleeding episodes during cycles 2 to 7 | 168 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intracyclic bleeding days (including spotting) in Cycles 2 to 7 | 168 days | |
| Number of withdrawal bleeding episodes in Cycles 1 to 6 | 168 days | |
| Bleeding pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krumbach | Bavaria | 86381 | Germany | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Arm 5 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891) dose 5 (80458712) for days 17-24, and placebo for 4 days in a 28 day cycle |
|
| Arm 6 | Experimental | E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891)dose 5 (80458712) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 2 (80458690) for one day in a 28 day cycle |
|
| E2/DRSP (BAY 86-4891) dose 2 (80458739) | Drug | Single dose administration of E2 + DRSP as a tablet |
|
| E2/DRSP (BAY 86-4891) dose 3 (80458755) | Drug | Single dose administration of E2 + DRSP as a tablet |
|
| E2/DRSP (BAY 86-4891) dose 4 (80458720) | Drug | Single dose administration of E2 + DRSP as a tablet |
|
| E2/DRSP (BAY 86-4891) dose 5 (80458712) | Drug | Single dose administration of E2 + DRSP as a tablet |
|
| DRSP (ZK 30595) dose 1 (SH T04984F) | Drug | Single dose administration of DRSP as a tablet |
|
| DRSP (ZK 30595) dose 2 (80458690) | Drug | Single dose administration of DRSP as a tablet |
|
| Placebo | Drug | Placebo administration in each arm |
|
Bleeding pattern was determined by: - Number of bleeding/spotting days - Number of bleeding days (excluding spotting) - Number of spotting-only days - Number, mean length, maximum length, and range of length of bleeding/spotting episodes - Number, mean length, maximum length, and range of length of spotting-only episodes |
| Approximately 7 months |
| Cycle control | Withdrawal bleeding - Number of volunteers with/without withdrawal bleeding; - Length, maximum intensity, and onset of withdrawal bleeding episodes Intracyclic bleeding (including/excluding spotting) - Number of volunteers with/without intracyclic bleeding; - Number, maximum length, maximum intensity (including spotting only) of intracyclic bleeding episodes - Number of intracyclic bleeding days - Number of volunteers with at least one intracyclic bleeding (including/excluding spotting) episode in Cycles 2 - 6 and in Cycles 2 - 7 | Approximately 7 months |
| Subjective assessment of treatment | The treatment satisfaction assessment was done through a questionaire. The investigator handed it over to the subject and the subject was asked to answer all questions by herself. | Day 196 - Day 210 |
| Number of participants with adverse events | Approximately 7 months |
| Nuremberg |
| Bavaria |
| 90491 |
| Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 21073 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 22159 | Germany |
| Dietzenbach | Hesse | 63128 | Germany |
| Frankfurt am Main | Hesse | 60322 | Germany |
| Frankfurt am Main | Hesse | 65936 | Germany |
| Fulda | Hesse | 36037 | Germany |
| Mühlheim am Main | Hesse | 63165 | Germany |
| Dippoldiswalde | Saxony | 01744 | Germany |
| Dresden | Saxony | 01099 | Germany |
| Dresden | Saxony | 01169 | Germany |
| Leipzig | Saxony | 04207 | Germany |
| Leipzig | Saxony | 04299 | Germany |
| Wurzen | Saxony | 04808 | Germany |
| Blankenburg | Saxony-Anhalt | 38889 | Germany |
| Burg | Saxony-Anhalt | 39288 | Germany |
| Jessen | Saxony-Anhalt | 06917 | Germany |
| Magdeburg | Saxony-Anhalt | 39104 | Germany |
| Magdeburg | Saxony-Anhalt | 39126 | Germany |
| Berlin | State of Berlin | 10247 | Germany |
| Berlin | State of Berlin | 12587 | Germany |
| Berlin | State of Berlin | 13086 | Germany |
| Berlin | State of Berlin | 13507 | Germany |
| Gera | Thuringia | 07545 | Germany |
| ID | Term |
|---|---|
| C035144 | drospirenone |
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