Study Completed

Contraception

Bayer Identifier:

14688

ClinicalTrials.gov Identifier:

NCT00931827

EudraCT Number:

Not Available

EU CT Number:

Not Available

Acceptability of long-term progestin-only contraception in Europe

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.

Key Participants Requirements

Sex

Female

Age

20 - 35 Years

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

January 2008 - November 2011

Phase

N/A

Could I Receive a placebo

Products

Mirena (Levonorgestrel IUS, BAY86-5028)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, United Kingdom
Completed		Many Locations, France
Completed		Many Locations, Slovakia
Completed		Many Locations, Ireland

Primary Outcome

Continuation rate
Time Frame:
At 24 months
Safety Issue:
No

Secondary Outcome

Continuation rate
Time Frame:
At 12 months
Safety Issue:
No
Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)
Time Frame:
Initial and after 3, 6, 12 and 24 months
Safety Issue:
No
Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons
Time Frame:
At 24 months
Safety Issue:
No
Incidence of Adverse Events, Serious Adverse Events
Time Frame:
During 24 months
Safety Issue:
Yes
The return to fertility of women discontinuing the method for wish for pregnancy
Time Frame:
12 months after discontinuation
Safety Issue:
No

Trial design

Acceptability of long-term progestin-only contraception in Europe

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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