Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)

NCT ID: NCT01650168

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101498 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2020-12-31

Brief Summary

This study compares the risks of short- and long-term use of NOMAC-E2 (containing a fixed dose of nomegestrol acetate and estradiol) compared with levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population representative of the actual users of the individual preparations.

Detailed Description

NOMAC-E2 is a novel monophasic oral contraceptive containing a fixed dose of nomegestrol acetate (2.5mg) and 17ß-estradiol (1.5mg) which is taken for 24 days followed by 4 days of placebo. The most relevant adverse clinical outcome that has been linked to the use of COCs is venous thromboembolism (VTE). Data from randomized clinical trials did not show any serious health concerns for NOMAC-E2. However, the statistical power to detect rare adverse events is limited in these studies.

PRO-E2 is a large, prospective, controlled, long-term active surveillance study to investigate the safety of NOMAC-E2 with regard to the outcomes of interest. This study follows the European Active Surveillance (EURAS) design methodology with some modifications due to country- and product-specific characteristics. The outcomes of interest will be validated via the attending physicians. A multi-faceted follow-up procedure will ensure a low loss to follow-up rate. This study will involve women from Europe and Australia who will be followed for up to 2 years. Data analysis will include multivariable techniques such as Cox regression.

Conditions

Contraception

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NOMAC-E2

New users of NOMAC-E2

No interventions assigned to this group

LNG-COCs

New users of levonorgestrel-containing COCs

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• First ever user of a COC ("starter")
• User who restarts hormonal contraceptive use with a COC (same COC as before or a new COC) after an intake break of at least two months ("restarters")
• Women willing to participate in the active surveillance

Exclusion Criteria

• Women who do not understand the major aspects of the study

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Theramex

INDUSTRY

Sponsor Role: collaborator

Center for Epidemiology and Health Research, Germany

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaas Heinemann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Epidemiology and Health Research, Berlin, Germany

Locations

Center for Epidemiology and Health Research Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

ZEG2013_08

Identifier Type: -

Identifier Source: org_study_id