Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice (MARILIA)

Bayer

Status: Completed

Conditions: Female Contraception

Treatments: Drug: Levonorgestrel IUD (Mirena, BAY86-5028)

Study type: Observational

Funder types: Industry

Identifiers

NCT01833793

16314

MA1211DZ (Other Identifier)

Details and patient eligibility

About

MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19-40 years at the time of Mirena IUD insertion
• Using Mirena only for contraception indication
• Never having used the product before
• No heavy menstrual bleeding diagnosed
• Have signed informed consent to participate in this study

Exclusion criteria

• Nulliparous
• Pregnancy
• Mirena's contre-indication
• Mirena for HMB
• Abnormal bleeding pattern

Trial design

35 participants in 1 patient group

Group 1

Treatment:

Drug: Levonorgestrel IUD (Mirena, BAY86-5028)