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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00653614 |
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.
Condition | Intervention | Phase |
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Oral Contraceptive |
Drug: E2/DRSP |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Center, Double-Blind, Randomized, Parallel-Group Study to Evaluate Cycle Control and Safety of 6 Different Regimens of an Oral Contraceptive Containing Estradiol and Drospirenone in Healthy Female Volunteers Aged Between 18 and 35 Years Over 7 Cycles |
Estimated Enrollment: | 600 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | May 2009 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: E2/DRSP
Monophasic regimen containing estrogen and progestin
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Arm 2: Experimental |
Drug: E2/DRSP
Monophasic regimen containing estrogen and progestin
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Arm 3: Experimental |
Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin
|
Arm 4: Experimental |
Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin
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Arm 5: Experimental |
Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin
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Arm 6: Experimental |
Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin
|
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at Visit
1 or a normal result has to be documented within the last 6 months before Visit 1)
Germany | |
Berlin, Germany, 13086 | |
Berlin, Germany, 12587 | |
Berlin, Germany, 10247 | |
Hamburg, Germany, 21073 | |
Hamburg, Germany, 22159 | |
Berlin, Germany, 13507 | |
Germany, Bayern | |
Nürnberg, Bayern, Germany, 90491 | |
Krumbach, Bayern, Germany, 86381 | |
Germany, Hessen | |
Dietzenbach, Hessen, Germany, 63128 | |
Frankfurt, Hessen, Germany, 60322 | |
Fulda, Hessen, Germany, 36037 | |
Frankfurt, Hessen, Germany, 65936 | |
Mühlheim, Hessen, Germany, 63165 | |
Germany, Sachsen | |
Leipzig, Sachsen, Germany, 04299 | |
Dresden, Sachsen, Germany, 01099 | |
Wurzen, Sachsen, Germany, 04808 | |
Leipzig, Sachsen, Germany, 04207 | |
Dresden, Sachsen, Germany, 01169 | |
Dippoldiswalde, Sachsen, Germany, 01744 | |
Germany, Sachsen-Anhalt | |
Blankenburg, Sachsen-Anhalt, Germany, 38889 | |
Magdeburg, Sachsen-Anhalt, Germany, 39126 | |
Magdeburg, Sachsen-Anhalt, Germany, 39104 | |
Burg, Sachsen-Anhalt, Germany, 39288 | |
Jessen, Sachsen-Anhalt, Germany, 06917 | |
Germany, Thüringen | |
Gera, Thüringen, Germany, 07545 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91765, EudraCT No.: 2007-005258-22, 311926 |
Study First Received: | April 2, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00653614 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Oral contraception |
Estradiol 3-benzoate Estradiol valerate Drospirenone Estradiol 17 beta-cypionate |
Healthy Polyestradiol phosphate Estradiol |