Acceptability of Long-term Progestin-only Contraception in Europe

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00931827
• Collaborator: (none)
• Enrollment: 436
• Locations: 4
• Duration (Months): 46
• Patients Per Site: 109
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Levonorgestrel IUS (Mirena, BAY86-5028); Drug: Implanon (Etonogestrel)

Study Design

• Study Type: Observational
• Actual Enrollment: 436 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Acceptability of Long-term Progestin-only Contraception in Europe
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Levonorgestrel IUS (Mirena, BAY86-5028); Patients under daily life treatment receiving Mirena according to local drug information.
Group 2	Drug: Implanon (Etonogestrel); Patients under daily life treatment receiving Implanon according to local drug information.

Outcome Measures

Primary Outcome Measures

1. Continuation rate [At 24 months]

Secondary Outcome Measures

1. Continuation rate [At 12 months]

2. Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient) [Initial and after 3, 6, 12 and 24 months]

3. Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons [At 24 months]

4. Incidence of Adverse Events, Serious Adverse Events [During 24 months]

5. The return to fertility of women discontinuing the method for wish for pregnancy [12 months after discontinuation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		France
2		Many Locations		Ireland
3		Many Locations		Slovakia
4		Many Locations		United Kingdom

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00931827
• Other Study ID Numbers: 14688; MA0801; 14239; 14177; 14176; 14016
• First Posted: Jul 2, 2009
• Last Update Posted: Dec 24, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Bayer: Contraception
• Additional relevant MeSH terms: Levonorgestrel; Etonogestrel

Study Results

No Results Posted as of Dec 24, 2013