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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01650168
Recruitment Status : Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Theramex
Information provided by (Responsible Party):
Center for Epidemiology and Health Research, Germany

Study Description
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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.

Condition or disease
Contraception

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 Design
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Study Type : Observational
Estimated Enrollment : 101000 participants
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)
Study Start Date : July 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Groups and Cohorts
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Group/Cohort
NOMAC-E2
New users of NOMAC-E2
LNG-COCs
New users of levonorgestrel-containing COCs


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

Secondary Outcome Measures :
  1. Arterial thromboembolisms (ATE) [ Time Frame: Within 2 years ]
  2. Depressive disorders [ Time Frame: Within 2 years ]
  3. Cholelithiasis [ Time Frame: Within 2 years ]
  4. Inflammatory bowel disease [ Time Frame: Within 2 years ]
  5. Short- and long-term fertility [ Time Frame: Within 2 years ]
  6. Drug utilization pattern [ Time Frame: Within 2 years ]
  7. Pregnancy outcomes [ Time Frame: Within 2 years ]
  8. Weight change [ Time Frame: Within 2 years ]
  9. General hepatobiliary disorders [ Time Frame: Within 2 years ]
  10. Acne [ Time Frame: Within 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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


Locations
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Germany
Center for Epidemiology and Health Research Berlin
Berlin, Germany
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Merck Sharp & Dohme Corp.
Theramex
Investigators
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Principal Investigator: Klaas Heinemann, MD, PhD Center for Epidemiology and Health Research, Berlin, Germany
More Information
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Responsible Party: Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01650168    
Other Study ID Numbers: ZEG2013_08
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by Center for Epidemiology and Health Research, Germany:
NOMAC-E2
Nomegestrol acetate
Estradiol
Levonorgestrel
Safety