NCT01009684

Brief Summary

The primary objective of the study is to assess the risks of short and long-term use of estradiol valerate/dienogest (EV/DNG) and of established oral contraceptives (OCs) in a study population that is representative for the actual users of the individual preparations. This includes an estimate of the absolute risk of rare serious adverse outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50,203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

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

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

7.5 years

First QC Date

November 6, 2009

Last Update Submit

June 14, 2019

Conditions

Contraception

Keywords

ContraceptionEstradiol valerate

Outcome Measures

Primary Outcomes (3)

  • Venous Thromboembolic Events (VTE)

    up to 7 years

  • Acute Myocardial Infarction (AMI)

    up to 7 years

  • Cerebrovascular Accidents (CVA)

    up to 7 years

Study Arms (2)

DNG/EV

Users of the oral contraceptive containing Dienogest and Estradiol valerate

Other OCs

Users of oral contraceptives (OCs) containing other progestins and estrogens

Eligibility Criteria

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

Study participants are recruited by their attending gynecologists. The sample should be representative of users of oral contraceptives (OCs).

You may qualify if:

  • women who have a new prescription for an OC
  • women who are willing to participate in this long-term follow-up study

You may not qualify if:

  • women who are not cooperative
  • women with a language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berlin Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Related Publications (2)

  • Dinger J, Do Minh T, Heinemann K. Impact of estrogen type on cardiovascular safety of combined oral contraceptives. Contraception. 2016 Oct;94(4):328-39. doi: 10.1016/j.contraception.2016.06.010. Epub 2016 Jun 22.

    PMID: 27343748RESULT

  • Barnett C, Hagemann C, Dinger J, Do Minh T, Heinemann K. Fertility and combined oral contraceptives - unintended pregnancies and planned pregnancies following oral contraceptive use - results from the INAS-SCORE study. Eur J Contracept Reprod Health Care. 2017 Feb;22(1):17-23. doi: 10.1080/13625187.2016.1241991. Epub 2016 Oct 17.

    PMID: 27749101RESULT

Study Officials

  • Klaas Heinemann, PhD, MD, MSc

    Berlin Center for Epidemiology and Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

DE(1)