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Choice of Estrogens and Longterm Investigation of Nomegestrol Acetate - International Active Surveillance Study (INAS-CELINA)

This study is currently recruiting participants.
Verified July 2012 by Center for Epidemiology and Health Research, Germany
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT01650168
First received: July 13, 2012
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  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 established combined oral contraceptives (COCs) 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: Choice of Estrogens and Longterm Investigation of Nomegestrol Acetate - International Active Surveillance Study (INAS-CELINA)

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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

Primary Outcome Measures:
  • Venous thromboembolisms (VTE) [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Arterial thromboembolisms (ATE) [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]
  • Depressive disorders [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]
  • Cholelithiasis [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]
  • Inflammatory bowel disease [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]
  • Short- and long-term fertility [ Time Frame: Within 5 years ] [ Designated as safety issue: No ]
  • Drug utilization pattern [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]
  • Pregnancy outcomes [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]
  • Weight change [ Time Frame: Within 5 years ] [ Designated as safety issue: No ]
  • General hepatobiliary disorders [ Time Frame: Within 5 years ] [ Designated as safety issue: Yes ]
  • Acne [ Time Frame: Within 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 61500
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
NOMAC-E2
New users of NOMAC-E2
Other COCs
New users of other marketed 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.

INAS-CELINA 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 5 years. Data analysis will include multivariable techniques such as Cox regression.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women using oral contraceptives

Criteria

Inclusion Criteria:

  • Women starting COC use for the first time ("starter")
  • Women switching from one COC (or hormonal contraceptive) to another COC without a pill break ("switchers")
  • Women restarting oral contraceptive use with a COC (same COC as before or a new COC) after a pill intake break of at least 4 weeks ("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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650168

Contacts
Contact: Suzanne Reed, MSc, PhD +49 30 945 101 63 reed@zeg-berlin.de
Contact: Kristina Bardenheuer, MSc +49 30 945 101 62 bardenheuer@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
Investigators
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research, Berlin, Germany
  More Information

No publications provided

Responsible Party: Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01650168     History of Changes
Other Study ID Numbers: ZEG2011_04
Study First Received: July 13, 2012
Last Updated: July 23, 2012
Health Authority: European Union: European Medicines Agency

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

Additional relevant MeSH terms:
Estrogens
Megestrol
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 19, 2013