Acceptability of Long-term Progestin-only Contraception in Europe

Bayer

Status: Completed

Conditions: Contraception

Treatments: Drug: Implanon (Etonogestrel); Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Study type: Observational

Funder types: Industry

Identifiers

NCT00931827

14016 (Other Identifier)

14688

MA0801 (Other Identifier)

14177

14176 (Other Identifier)

14239 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 436 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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 design

436 participants in 2 patient groups

Group 1

Treatment:

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Group 2

Treatment:

Drug: Implanon (Etonogestrel)