Contraception
Conditions
Keywords
Contraception, Intrauterine contraception system
Brief summary
The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.
Interventions
DRUGLevonorgestrel IUS (LCS, BAY86-5028)
In Vitro release rate: 12µg LNG/24h
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS. * Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.) * Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion). * Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
Exclusion criteria
* Known or suspected pregnancy or is lactating. * Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2. Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation. * History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation. * Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1. * Abnormal uterine bleeding of unknown origin. * Any genital infection (until successfully treated). * History of, or current, pelvic inflammatory disease * Congenital or acquired uterine anomaly. * Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS. * History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia. * Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis. * Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study * Clinically significant ovarian cyst(s) * Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| LCS expulsion rate | 3 years |
| Discontinuation rates | 3 years |
| Adverse events | 3 years |
| Laboratory tests | 3 years |
Countries
Australia, China, South Korea
Outcome results
None listed