Contraception or menorrhagia MedDRA version: 8.1 Level: LLT Classification code 10010808 Term: Contraception
Conditions
Interventions
Trade Name: Mirena
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: levonorgestrel
CAS Number: 797-63-7
Current Sponsor code: zk18206
Concentration unit: mg milligram(s)
Concentr
Sponsors
Schering Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent. Woman of 23 to 45 years of age (inclusive) who is currently using MIRENA for contraception or menorrhagia, her duration use is between 4 years 3 months and 4 years 9 months and she is willing to continue with the method. Normal size uterus at insertion, corresponding to sound measure of 6-10 cm. Clinically normal cervical smear result within 12 preceding months or at screening. Clinically normal breast examination findings. For patients = 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required. Willingness and ability to attend the clinic for scheduled visits and to comply with the study procedures. Additional inclusion criteria for misoprostol subset: Willingness to accept pretreatment as allocated through randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms. Known or suspected pregnancy. Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity. Current or recurrent pelvic inflammatory disease. Abnormal uterine bleeding of unknown origin. Acute cervicitis or vaginitis not responding to treatment. History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia. Any active acute liver disease or liver tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the bleeding profile during the first year of use of the second consecutive MIRENA.;Secondary Objective: The secondary objectives are assessment of the removal of the first MIRENA (by investigator and patient) and the insertion of the second MIRENA (by investigator and patient), continuation rate, pregnancy rate, menstrual comfort and user satisfaction during the first year of use.;Primary end point(s): The primary efficacy variable in the study is the assessment of occurrence and intensity of bleeding during the last 3 months of the first MIRENA and the first year of the second MIRENA use. | — |
Countries
Finland, Ireland, Sweden
Outcome results
None listed