Trial Condition(s):
Medicated Intrauterine Devices, Contraception
Mirena efficiency and tolerability during the first year of use
Bayer Identifier:
91295
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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- Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of MirenaTimeframe: within 12 months after randomization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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