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. (see Contacts and Locations)
Verified July 2014 by Center for Epidemiology and Health Research, Germany
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Theramex
Information provided by (Responsible Party):
Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT01650168
First received: July 13, 2012
Last updated: July 30, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Arterial thromboembolisms (ATE) [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]
  • Depressive disorders [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]
  • Cholelithiasis [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]
  • Inflammatory bowel disease [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]
  • Short- and long-term fertility [ Time Frame: Within 2 years ] [ Designated as safety issue: No ]
  • Drug utilization pattern [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]
  • Pregnancy outcomes [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]
  • Weight change [ Time Frame: Within 2 years ] [ Designated as safety issue: No ]
  • General hepatobiliary disorders [ Time Frame: Within 2 years ] [ Designated as safety issue: Yes ]
  • Acne [ Time Frame: Within 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 101000
Study Start Date: July 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: June 2017 (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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Theramex
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: ZEG2013_08
Study First Received: July 13, 2012
Last Updated: July 30, 2014
Health Authority: European Union: European Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 21, 2014