Acceptability of Long-term Progestin-only Contraception in Europe

Contraception Clinical Trial

Official title:

Acceptability of Long-term Progestin-only Contraception in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931827
• Other study ID #: 14688
• Secondary ID: MA08011423914177
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: December 22, 2013
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: December 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityUnited Kingdom: Research Ethics CommitteeIreland: Medical Ethics Research CommitteeSlovakia: State Institute for Drug Control
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUS (Mirena, BAY86-5028)
Patients under daily life treatment receiving Mirena according to local drug information.
• Implanon (Etonogestrel)
Patients under daily life treatment receiving Implanon according to local drug information.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Ireland,  Slovakia,  United Kingdom, 

Outcome

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

External Links

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