Long-term Active Surveillance Study for Oral Contraceptives (LASS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term Active Surveillance Study for Oral Contraceptives (LASS)

Conditions
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Arterial Thromboembolism, Venous Thromboembolism, Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation Exclusion Criteria: Women who do not consent to participate in the study
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women who take oral contraceptives containing drospirenone | |
| 2<br>Women who take oral contraceptives containing levonorgestrel | |
| 3<br>Women who take oral contraceptives containing other progestogens | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Thromboembolism, Breast Cancer