NCT01650168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101,498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

8.4 years

First QC Date

July 13, 2012

Last Update Submit

July 27, 2021

Conditions

Contraception

Keywords

NOMAC-E2Nomegestrol acetateEstradiolLevonorgestrelSafety

Outcome Measures

Primary Outcomes (1)

  • Venous thromboembolisms (VTE)

    Within 2 years

Secondary Outcomes (10)

  • Arterial thromboembolisms (ATE)

    Within 2 years

  • Depressive disorders

    Within 2 years

  • Cholelithiasis

    Within 2 years

  • Inflammatory bowel disease

    Within 2 years

  • Short- and long-term fertility

    Within 2 years

  • +5 more secondary outcomes

Study Arms (2)

NOMAC-E2

New users of NOMAC-E2

LNG-COCs

New users of levonorgestrel-containing COCs

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women using oral contraceptives

You may qualify if:

  • 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

You may not qualify if:

  • \- Women who do not understand the major aspects of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Epidemiology and Health Research Berlin

Berlin, Germany

Location

Study Officials

  • Klaas Heinemann, MD, PhD

    Center for Epidemiology and Health Research, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 26, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

DE(1)