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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.
Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. This study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations.
INAS-OC is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen. New users of an OC (starters, switchers without a pill intake break and recurrent users with a pill intake break [same or different OC]) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Users of OCs containing DRSP | ||
| 2 | Users of OCs containing other progestins |
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| Measure | Description | Time Frame |
|---|---|---|
| Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs | Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. | Within 60 months |
| Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs | Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups. | Within 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Women using oral contraceptives
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| Name | Affiliation | Role |
|---|---|---|
| Juergen C Dinger, MD, PhD | Center for Epidemiology and Health Research, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Epidemiology and Health Research | Berlin | 10115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24576793 | Derived | Dinger J, Bardenheuer K, Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives. Contraception. 2014 Apr;89(4):253-63. doi: 10.1016/j.contraception.2014.01.023. Epub 2014 Feb 4. | |
| 21213475 |
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Overall, 91,474 patients were recruited for the INAS-OC study. Of these, 6,365 participants were excluded due to protocol violations.
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| ID | Title | Description |
|---|---|---|
| FG000 | OC DRSP-24d | OCs containing DRSP (Yaz®, 24 day regimen) |
| FG001 | OC DRSP-21d | OCs containing DRSP (Yasmin®, 21 day regimen) |
| FG002 | OCs Non-DRSP | Users of OCs containing other progestins |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OC DRSP-24d | OCs containing DRSP (Yaz®, 24 day regimen ) |
| BG001 | OC DRSP-21d | OCs containing DRSP (Yasmin®, 21 day regimen) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs | Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. | Study participants that were not excluded due to protocol violation | Posted | Number | participants | Within 60 months |
|
Information on adverse events was collected over a time period of 5 years.
Complete cohorts, as-treated population. All study participants were asked for adverse events at each follow-up. The total number of serious adverse events do not include 132 SAEs (due to data entry options), for which information on organ system is missing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DRSP-24d | 24-day regimen of DRSP/EE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious diseases | Infections and infestations | ICD-10 | Systematic Assessment |
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In non-experimental studies the possibility of bias and residual confounding can never be entirely eliminated. The findings may exclude large, but not small relative risks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juergen Dinger, MD, PhD | Center for Epidemiology and Health Research, Germany | 0049(0)30 945 10120 | dinger@zeg-berlin.de |
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| Dinger J, Do Minh T, Buttmann N, Bardenheuer K. Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen. Obstet Gynecol. 2011 Jan;117(1):33-40. doi: 10.1097/AOG.0b013e31820095a2. |
| BG002 | OCs Non-DRSP | Users of OCs containing other progestins |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OCs Non-DRSP |
Users of OCs containing other progestins than DRSP |
| OG003 | NOHC | Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches) |
| OG004 | No Use | No (hormonal) contraception at last contact |
|
|
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| Primary | Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs | Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups. | Study participants that were not excluded due to protocol violation | Posted | Number | participants | Within 60 months |
|
|
|
| 583 |
| 7,264 |
| 0 |
| 7,264 |
| EG001 | DRSP-21d | 21-day regimen of DRSP/EE | 499 | 5,605 | 0 | 5,605 |
| EG002 | OCs Non-DRSP | Users of OCs containing other progestins | 2,740 | 39,316 | 0 | 39,316 |
| EG003 | NOHC | Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches) | 254 | 4,070 | 0 | 4,070 |
| EG004 | No Use | No (hormonal) contraception) | 1,756 | 28,854 | 0 | 28,854 |
| Neoplasms, malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 | Systematic Assessment |
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| Neoplasms, benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 | Systematic Assessment |
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| Diseases of the blood and blood-forming organs | Blood and lymphatic system disorders | ICD-10 | Systematic Assessment |
|
| Endocrine diseases | Endocrine disorders | ICD-10 | Systematic Assessment |
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| Psychiatric and neurological disorders | Psychiatric disorders | ICD-10 | Systematic Assessment |
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| Eye | Eye disorders | ICD-10 | Systematic Assessment |
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| Ear | Ear and labyrinth disorders | ICD-10 | Systematic Assessment |
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| Cardiovascular system | Cardiac disorders | ICD-10 | Systematic Assessment |
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| Respiratory system | Respiratory, thoracic and mediastinal disorders | ICD-10 | Systematic Assessment |
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| Digestive system | Gastrointestinal disorders | ICD-10 | Systematic Assessment |
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| Skin | Skin and subcutaneous tissue disorders | ICD-10 | Systematic Assessment |
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| Musculoskeletal system and connective tissue | Musculoskeletal and connective tissue disorders | ICD-10 | Systematic Assessment |
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| Genitourinary system | Reproductive system and breast disorders | ICD-10 | Systematic Assessment |
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| Pregnancy, delivery and puerperium | Pregnancy, puerperium and perinatal conditions | ICD-10 | Systematic Assessment | SAEs, which occurred within 3 months after stop of hormonal contraceptive use, were attributed to the last OC/NOHC used by the women. Therefore, pregnancy related SAEs in OC/NOHC cohorts do not reflect unwanted pregnancies during OC/NOHC use. |
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| Injury, poisoning, accidents, etc | Injury, poisoning and procedural complications | ICD-10 | Systematic Assessment |
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| of which acute myocardial infarction |
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| of which ichemic stroke |
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| of which transient ischemic attack (TIA) |
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| of which peripheral ATE |
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