Study Completed

Contraception

Bayer Identifier:

13764

ClinicalTrials.gov Identifier:

NCT01009684

EudraCT Number:

Not Available

EU CT Number:

Not Available

Dienogest INAS Study

Trial purpose

The INAS-SCORE study was designed as an international, prospective, controlled, non-interventional cohort study. The study was started in Europe and was extended to the US after the launch of the new regimen. New users of an OC (starters or switchers) are accrued by a network of prescribing physicians. Even in the event of high drop-out rates, a 3 to 5-year follow-up of 50,000 women should be sufficient to document about 150,000 women-years. Baseline and follow-up information are collected via a self-administered questionnaire. All self-reported clinical outcomes of interest will be validated via health care professionals. Classification of reported outcomes as "confirmed" or "unconfirmed" will be checked via blinded, independent adjudication. A multifaceted 4-level follow-up procedure proved to ensure low loss to follow-up rates.
The main clinical outcomes of interest for the short and long-term follow-up are cardiovascular events, primarily deep venous thrombosis, pulmonary embolism, acute myocardial infarction, and cerebrovascular accidents.

Key Participants Requirements

Sex

Female

Age

N/A

Inclusion Criteria
- Women who received a new prescription for a combined oral contraceptive.
- Participating physicians discussed the study with the subjects only after a COC had been prescribed. This ensured that study participation in the study was not considered a requirement for treatment. All women who were eligible for recruitment were asked to participate.
- Participating women could be starters (first-ever users of COCs), switchers (users who switched from one COC to another ‒ without an intake break or an intake break of less than 4 weeks), or restarters (users who restarted a COC after an intake break of at least 4 weeks, i.e. at least one complete cycle).
Exclusion Criteria
- women who are not cooperative
- women with a language barrier

More specific inclusion or exclusion criteria were not made because of the non-interference approach of the study design.

Trial summary

Enrollment Goal

50203

Trial Dates

September 2009 - April 2017

Phase

Phase 4

Could I Receive a placebo

Products

Natazia/Qlaira (EV/DNG, BAY86-5027)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Completed		Berlin, 10115, Germany

Primary Outcome

New VTE [mainly deep venous thrombosis (DVT) and pulmonary embolism (PE))
New ATE [mainly acute myocardial infarction (AMI) and cerebrovascular accidents (CVA))

Trial design

International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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