Trial Condition(s):
Medicated Intrauterine Devices, Contraception
Mirena efficiency and tolerability during the first year of use
Study Completed
Trial Purpose
In this trial the efficacy and safety of Mirena was investigated during the first year of use
Inclusion Criteria
- Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).
Exclusion Criteria
- Standard exclusion criteria for use of intrauterine hormone devices
Trial Summary
Enrollment Goal
199
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
Status
| Locations | Status | ||
|---|---|---|---|
Locations Centre de Gynecologie Obstetrique Amiens Cedex 01, France, 80054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multicentre, open label, uncontrolled study of the tolerance, acceptability and contraceptive efficacy of Mirena 52 mg®, an intra-uterine levonorgestrel device, during the first year after insertion post-partum
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of MirenaTimeframe: within 12 months after randomization
Secondary Outcome
- General safety assessmentTimeframe: within 12 months after randomization
Additional Information
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