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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.
The LASS Study is a large, multinational, prospective, controlled, non-interventional, long-term cohort study that follows a series of cohorts. The cohorts consist of new users (first-ever users, switchers and restarters) of three different groups of oral contraceptives (OCs): OCs containing drospirenone (DRSP), OCs containing levonorgestrel (LNG) and OCs containing other progestogens. A "non-interference" approach is used to provide standardized, comprehensive, reliable information on these groups of OCs under routine medical conditions.
The main clinical outcomes of interest for the long-term follow-up are arterial and venous thromboembolism as well as breast cancer. Regular, active contacts with the cohort members (=active surveillance) provide all necessary information on health-related events or changes in health status.
The study is based on the existing long-term EURAS cohorts who are still in follow-up. LASS succeeds EURAS and prolongs the follow-up period for another five years. Total follow-up time of members of the long-term cohorts will be between 6 and 10 years. By means of annual contacts almost all relevant clinical outcomes will be captured. This will be accomplished by contacting the relevant physicians and by reviewing relevant source documents in the case of relevant clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Women who take oral contraceptives containing drospirenone | ||
| 2 | Women who take oral contraceptives containing levonorgestrel | ||
| 3 | Women who take oral contraceptives containing other progestogens |
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| Measure | Description | Time Frame |
|---|---|---|
| Arterial Thromboembolism | Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens. | Within 10 years |
| Venous Thromboembolism | Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens. | Within 10 years |
| Breast Cancer | Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP. | Within 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Women attending offices of oral contraceptives prescribing physicians
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| Name | Affiliation | Role |
|---|---|---|
| Juergen 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 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26825258 | Derived | Dinger J, Mohner S, Heinemann K. Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives. Contraception. 2016 May;93(5):378-85. doi: 10.1016/j.contraception.2016.01.012. Epub 2016 Jan 26. |
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In the LASS study, 59,510 women were recruited overall. Of these, 836 participants were excluded due to protocol violation (e.g. patient did not start OC use). Furthermore, 371 patients started treatment with non-oral contraceptives. These patients were followed-up but were not part of the per protocol Population (58,303 patients).
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| ID | Title | Description |
|---|---|---|
| FG000 | Yasmin | Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol |
| FG001 | OC-LNG | Users of oral contraceptives containing levonorgestrel |
| FG002 | OC-other | Users of oral contraceptives containing other progestogens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DRSP/EE | Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol |
| BG001 | OC-LNG | Users of oral contraceptives containing levonorgestrel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Arterial Thromboembolism | Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens. | The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition. | Posted | Number | participants | Within 10 years | Woman-years, AT-population | Participants |
|
Information on adverse events was collected over a time period of 10 years.
ITT population. All study participants were asked for adverse events at each follow-up.
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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/EE | Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol |
| 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 | +49 30 945 101 20 | dinger@zeg-berlin.de |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D001943 | Breast Neoplasms |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009371 | Neoplasms by Site |
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| BG002 | OC-other | Users of oral contraceptives containing other progestogens |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | This study was conducted in seven European countries: Austria, Belgium, Denmark, France, Germany, the Netherlands, and UK. | Number | participants |
|
| OG002 | OC-other | Users of oral contraceptives containing other progestogens |
|
|
|
| Primary | Venous Thromboembolism | Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens. | The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition. | Posted | Number | participants | Within 10 years | Woman-years, AT population | Participants |
|
|
|
|
| Primary | Breast Cancer | Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP. | The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition. | Posted | Number | participants | Within 10 years | Woman-years | Participants |
|
|
|
|
| 1,912 |
| 16,534 |
| 0 |
| 16,534 |
| EG001 | OC-LNG | Users of oral contraceptives containing levonorgestrel | 2,121 | 15,428 | 0 | 15,428 |
| EG002 | OC-other | Users of oral contraceptives containing other progestogens | 3,936 | 26,341 | 0 | 26,341 |
| Neoplasms, malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 | Systematic Assessment |
|
| Neoplasms, benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 | Systematic Assessment |
|
| Diseases of the blood and the bloodforming organs | Blood and lymphatic system disorders | ICD-10 | Systematic Assessment |
|
| Endocrine diseases | Endocrine disorders | ICD-10 | Systematic Assessment |
|
| Psychiatric & neurological disorders | Psychiatric disorders | ICD-10 | Systematic Assessment |
|
| Eye | Eye disorders | ICD-10 | Systematic Assessment |
|
| Ear | Ear and labyrinth disorders | ICD-10 | Systematic Assessment |
|
| Cardiovascular system | Cardiac disorders | ICD-10 | Systematic Assessment |
|
| Respiratory system | Respiratory, thoracic and mediastinal disorders | ICD-10 | Systematic Assessment |
|
| Digestive system | Gastrointestinal disorders | ICD-10 | Systematic Assessment |
|
| Skin | Skin and subcutaneous tissue disorders | ICD-10 | Systematic Assessment |
|
| Muscoskeletal system & connective tissue | Musculoskeletal and connective tissue disorders | ICD-10 | Systematic Assessment |
|
| Genitourinary system | Reproductive system and breast disorders | ICD-10 | Systematic Assessment |
|
| Pregnancy, delivery & puerperium | Pregnancy, puerperium and perinatal conditions | ICD-10 | Systematic Assessment | SAEs that occurred within 3 months after stop of OC use, were attributed to the last hormonal contraceptive used by the women. Therefore, pregnancy related SAEs on OC cohorts do not necessarily reflect unwanted pregnancies during HC use |
|
| Injury, poisoning, accidents, etc. | Injury, poisoning and procedural complications | ICD-10 | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2. | Hazard Ratio (HR) | 0.7 | 2-Sided | 95 | 0.5 | 1.0 | Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE. | Yes | Non-Inferiority or Equivalence | The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05. |
| Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2. | Hazard Ratio (HR) | 1.0 | 2-Sided | 95 | 0.6 | 1.5 | Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche. | Yes | Non-Inferiority or Equivalence | The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05. |