A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
NCT ID: NCT01388491
Last Updated: 2021-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
293 participants
INTERVENTIONAL
2011-10-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Treatment I: (DR-102)
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
desogestrel/ethinyl estradiol and ethinyl estradiol
Treatment II
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
desogestrel/ethinyl estradiol
Interventions
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desogestrel/ethinyl estradiol and ethinyl estradiol
desogestrel/ethinyl estradiol
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m²
* Regular spontaneous menstrual cycle
* Others as dictated by FDA-approved protocol
Exclusion Criteria
* Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
* Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
* Others as dictated by FDA-approved protocol
18 Years
40 Years
FEMALE
Yes
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Women's Health Research Protocol Chair
Role: STUDY_CHAIR
Teva Women's Health Research
Locations
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Teva Investigational Site 32064
Essen, , Germany
Teva Investigational Site 32065
Frankfurt, , Germany
Teva Investigational Site 32066
Frankfurt am Main, , Germany
Teva Investigational Site 32062
Hamburg, , Germany
Teva Investigational Site 32063
Hamburg, , Germany
Teva Investigational Site 32061
Magdeburg, , Germany
Teva Investigational Site 80013
Giv‘atayim, , Israel
Teva Investigational Site 80015
Haifa, , Israel
Teva Investigational Site 80017
Modiin, , Israel
Teva Investigational Site 80014
RishonLe'zio, , Israel
Teva Investigational Site 80018
Tel Aviv, , Israel
Teva Investigational Site 80016
Tel Aviv, , Israel
Teva Investigational Site 30014
Brescia, , Italy
Teva Investigational Site 30009
Cagliari, , Italy
Teva Investigational Site 30012
Catania, , Italy
Teva Investigational Site 30013
Napoli, , Italy
Teva Investigational Site 30010
Pavia, , Italy
Teva Investigational Site 30007
Pisa, , Italy
Teva Investigational Site 30016
Siena, , Italy
Teva Investigational Site 31017
Barcelona, , Spain
Teva Investigational Site 31015
Barcelona, , Spain
Teva Investigational Site 31014
Barcelona, , Spain
Teva Investigational Site 31016
Gava, Barcelona, , Spain
Teva Investigational Site 31012
Lugo, , Spain
Teva Investigational Site 31010
Madrid, , Spain
Teva Investigational Site 31011
Madrid, , Spain
Teva Investigational Site 31009
Vitoria-Gasteiz, , Spain
Countries
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References
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Peters K, Gordon N, Ricciotti N, Hsieh J, Howard B, Weiss H. Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study. Clin Exp Obstet Gynecol. 2016;43(3):334-40.
Other Identifiers
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DSG-HSP-201
Identifier Type: -
Identifier Source: org_study_id