NCT01266408

Brief Summary

The study compares the risks of short- and long-term use of contraceptives containing drospirenone (DRSP) or dienogest (DNG)/ethinylestradiol (EE) plus levomefolate calcium (metafolin) with the risks of short- and long-term use of other established oral contraceptives (OCs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82,921

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

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

November 22, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

8.9 years

First QC Date

December 23, 2010

Last Update Submit

July 27, 2020

Conditions

Contraception

Keywords

DrospirenoneDienogestMetafolinFolic acidSafety

Outcome Measures

Primary Outcomes (3)

  • Absolute risk of Venous Thromboembolic Events

    Within 6 years

  • Absolute risk of Acute Myocardial Infarction

    Within 6 years

  • Absolute risk of Cerebrovascular Accidents

    Within 6 years

Secondary Outcomes (2)

  • Colorectal cancer

    Within 6 years

  • Other cancer entities

    Within 6 years

Study Arms (2)

DRSP/EE/metafolin

Women using oral contraceptives containing drospirenone, ethinylestradiol and metafolin

Other OC users

Women using oral contraceptives containing other estrogen/progestogen combinations

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:

  • Women starting OC use ("starters")
  • Women switching OC use without a pill intake break ("switchers")
  • Women restarting OC use after a pill intake break ("restarters")
  • Women willing to participate in the active surveillance

You may not qualify if:

  • Long-term users
  • Women who do not agree to participate
  • Women with a language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Study Officials

  • Juergen C Dinger, PhD, MD

    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

December 23, 2010

First Posted

December 24, 2010

Study Start

November 22, 2010

Primary Completion

September 29, 2019

Study Completion

October 2, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

DE(1)