Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg) (PRO-E2)

July 27, 2021 updated by: Center for Epidemiology and Health Research, Germany
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

101498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Center for Epidemiology and Health Research Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women using oral contraceptives

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
NOMAC-E2
New users of NOMAC-E2
LNG-COCs
New users of levonorgestrel-containing COCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Venous thromboembolisms (VTE)
Time Frame: Within 2 years
Within 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Epidemiology and Health Research, Germany

Collaborators

Merck Sharp & Dohme LLC
Theramex

Investigators

  • Principal Investigator: Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZEG2013_08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe