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

This study is currently recruiting participants.
Verified May 2017 by Center for Epidemiology and Health Research, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650168
First Posted: July 26, 2012
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
Theramex
Information provided by (Responsible Party):
Center for Epidemiology and Health Research, Germany
  Purpose
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.

Condition
Contraception

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Controlled Cohort Study on the Safety of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate (2.5mg) and 17ß-estradiol (1.5mg)

Resource links provided by NLM:


Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Venous thromboembolisms (VTE) [ Time Frame: Within 2 years ]

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

Estimated Enrollment: 101000
Study Start Date: July 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
NOMAC-E2
New users of NOMAC-E2
LNG-COCs
New users of levonorgestrel-containing COCs

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women using oral contraceptives
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650168


Contacts
Contact: Suzanne Reed, MSc, PhD +49 30 945 101 63 reed@zeg-berlin.de
Contact: Klaas Heinemann, MD, PHD +49 30 945 101 20 k.heinemann@zeg-berlin.de

Locations
Germany
Center for Epidemiology and Health Research Berlin Recruiting
Berlin, Germany
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Merck Sharp & Dohme Corp.
Theramex
Investigators
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research, Berlin, Germany
  More Information

Responsible Party: Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01650168     History of Changes
Other Study ID Numbers: ZEG2013_08
First Submitted: July 13, 2012
First Posted: July 26, 2012
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by Center for Epidemiology and Health Research, Germany:
NOMAC-E2
Nomegestrol acetate
Estradiol
Levonorgestrel
Safety

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Levonorgestrel
Megestrol
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Antineoplastic Agents, Hormonal
Antineoplastic Agents