check_circleStudy Completed

Medicated Intrauterine Devices, Contraception

Bayer Identifier:

91295

ClinicalTrials.gov Identifier:

NCT00696202

EudraCT Number:

Not Available

EU CT Number:

Not Available
Mirena efficiency and tolerability during the first year of use

Trial purpose

In this trial the efficacy and safety of Mirena was investigated during the first year of use

Key Participants Requirements

Sex

Female

Age

25 - 39 Years
  • - 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).
  • - Standard exclusion criteria for use of intrauterine hormone devices

Trial summary

Enrollment Goal
199
Trial Dates
September 2003 - March 2005
Phase
Phase 4
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Centre de Gynecologie ObstetriqueAmiens Cedex 01, 80054, France

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  • Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena
    date_rangeTime Frame:
    within 12 months after randomization
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • General safety assessment
    date_rangeTime Frame:
    within 12 months after randomization
    enhanced_encryption
    Safety Issue:
    yes

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

Additional Information

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