NCT02078414

Brief Summary

Women using an emergency contraceptive method must use back up protection for 1-2 weeks depending on method. The Copper-IUD is the most effective emergency contraceptive method. The investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use of an effective contraceptive method 3 months and 6 months after the use of an emergency contraceptive method than women who choose to use the emergency contraceptive pill EllaOne (ulipristal acetate).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

March 3, 2014

Last Update Submit

November 28, 2023

Conditions

Emergency ContraceptionContraceptionReproductive Health

Outcome Measures

Primary Outcomes (1)

  • Use of an effective contraceptive method

    Use of pill, patch, ring, IUD, IUS, or injection 6 months after use of emergency contraceptive method

    6 months after emergency contraceptive use

Study Arms (2)

Ulipristal acetate

Women choosing EllaOne as emergency contraception

Copper IUD

Women choosing copper IUD as emergency contraception

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women without contraception or with a failed contraceptive method seeking emergency contraception

You may qualify if:

  • women over 18 years
  • eligible for all emergency contraception

You may not qualify if:

  • previous conisation
  • known stenosis of the cervix
  • signs of ongoing genital infection
  • known uterine anomaly
  • Known bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RFSU clinic

Stockholm, Sweden

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Obstetrics and Gynecology, PhD

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

SE(1)