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

Completed

• Conditions: Contraception

• Registration Number: NCT01650168
• Lead Sponsor: Center for Epidemiology and Health Research, Germany

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101498

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Venous thromboembolisms (VTE)	Within 2 years

Secondary Outcome Measures

Name	Time	Method
Arterial thromboembolisms (ATE)	Within 2 years
Inflammatory bowel disease	Within 2 years
Drug utilization pattern	Within 2 years
Pregnancy outcomes	Within 2 years
Weight change	Within 2 years
General hepatobiliary disorders	Within 2 years
Acne	Within 2 years
Depressive disorders	Within 2 years
Cholelithiasis	Within 2 years
Short- and long-term fertility	Within 2 years

Trial Locations

Locations (1)

Center for Epidemiology and Health Research Berlin; 🇩🇪 Berlin, Germany