Trial Condition(s):

Contraception

Acceptability of long-term progestin-only contraception in Europe

Bayer Identifier:

14688

ClinicalTrials.gov Identifier:

NCT00931827

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.

Inclusion Criteria
- Women aged 20-35 in good general health requesting contraception 
 - Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception 
 - Women who have given a written informed consent to participate in the study (if applicable)
Exclusion Criteria
- The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study 
 - Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern

Trial Summary

Enrollment Goal
436
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Slovakia

Status
Completed
 
Locations

Investigative Site

Many Locations, Ireland

Status
Completed
 

Trial Design