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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014911-11 | EudraCT Number |
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This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP (YAZ, BAY86-5300) | Drug | 4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales). | Cycle days 22 - 28 of baseline cycle and cycle 4. |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline to cycle 4 in the sum of individual scores during cycle days 22 - 28 (AUC of days 22 - 28 for each score), | Cycle days 22 - 28 of baseline cycle and cycle 4 | |
| change from baseline to cycle 4 in number of days, where individual hormone withdrawal symptoms are present on cycle days 22 - 28 (i.e. Likert Scale >= 1), |
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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 |
|---|---|---|---|---|---|---|
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1425ASQ | Argentina | |||
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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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| Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon) | Drug | 4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days |
|
| Cycle days 22 - 28 of baseline cycle and cycle 4 |
| change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28, | Cycle days 22 - 28 of baseline cycle and cycle 4 |
| rescue medication consumption | baseline cycle and cycle 4 |
| bleeding pattern | reference period is 90 days. |
| evaluation of questionnaires: Q-LES-Q (short version) | baseline cycle and cycle 4 |
| Adverse Event collection | up to 10 days after end of cycle 4 |
| heart rate | up to 10 days after end of cycle 4 |
| blood pressure | up to 10 days after end of cycle 4 |
| Rosario |
| Santa Fe Province |
| 2000 |
| Argentina |
| Santiago | Santiago Metropolitan | 7510025 | Chile |
| Santiago | Santiago Metropolitan | 836-0156 | Chile |
| Santiago | 838-0456 | Chile |
| Santiago | Chile |
| Temuco | 4790711 | Chile |
| Bucaramanga | Santander Department | Colombia |
| Bogotá | Colombia |
| Medellín | Colombia |
| Brno | 602 00 | Czechia |
| Prague | 120 00 | Czechia |
| Tábor | 39003 | Czechia |
| Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Fürth | Bavaria | 90763 | Germany |
| Hanover | Lower Saxony | 30459 | Germany |
| Leipzig | Saxony | 04207 | Germany |
| Magdeburg | Saxony-Anhalt | 39126 | Germany |
| Jena | Thuringia | 07747 | Germany |
| Florence | 50134 | Italy |
| Milan | 20132 | Italy |
| Siena | 53100 | Italy |
| Manila | Philippines |
| Pasig | Philippines |
| Lisbon | Lisbon District | 1649-035 | Portugal |
| Coimbra | 3000-061 | Portugal |
| Porto | 4200-319 | Portugal |
| Moscow | 117036 | Russia |
| Moscow | 123995 | Russia |
| Moscow | 177997 | Russia |
| Seoul | Korea | 100-380 | South Korea |
| Seoul | Korea | 138-736 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 135-710 | South Korea |
| Basel | Canton of Basel-City | 4031 | Switzerland |
| Bern | Canton of Bern | 3010 | Switzerland |
| Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Bangkok | Thailand | 10330 | Thailand |
| Songkhla | Thailand | 90110 | Thailand |
| Bangkok | 10700 | Thailand |
| Leeds | West Yorkshire | LS2 9AE | United Kingdom |
| Liverpool | L20 5DQ | United Kingdom |
| London | W12 0HS | United Kingdom |
| Caracas | Venezuela |
| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
| D004997 | Ethinyl Estradiol |
| D017135 | Desogestrel |
| C442659 | ethinyl estradiol-desogestrel combination |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009652 | Norpregnenes |
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