check_circleStudy Completed

Nulliparous

Bayer Identifier:

14015

ClinicalTrials.gov Identifier:

NCT00798980

EudraCT Number:

Not Available

EU CT Number:

Not Available
Scandinavian Mirena Insertion Nulliparous Trial.

Trial purpose

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.

Key Participants Requirements

Sex

Female

Age

14 Years
  • - Nulliparous women Mirena insertion planned as contraceptive method
  • - Ongoing or suspected pregnancy;
    - Ongoing or recidivating genital infection;
    - Cervicitis;
    - Cervical dysplasia;
    - Malignancy in uterus or cervix;
    - Confirmed or suspected hormone sensitive neoplasia including breast cancer
    - Undiagnosed abnormal uterine bleeding;
    - Uterine anomaly including myoma if the cavity of the uterus is restricted;
    - Conditions that cause increased risk of infections;
    - Acute liver disease or liver tumour;
    - Allergy to the active substance or any component of the IUD

Trial summary

Enrollment Goal
224
Trial Dates
February 2007 - November 2009
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Sweden

Primary Outcome

  • Evaluation of the insertion procedure of Mirena in nulliparous women
    date_rangeTime Frame:
    At the insertion time point
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Pain
    date_rangeTime Frame:
    At the insertion time point
    enhanced_encryption
    Safety Issue:
    Yes
  • Continuation rate
    date_rangeTime Frame:
    12-16 weeks post insertion
    enhanced_encryption
    Safety Issue:
    Yes
  • Bleeding Pattern
    date_rangeTime Frame:
    12-16 weeks post insertion
    enhanced_encryption
    Safety Issue:
    Yes
  • Satisfaction
    date_rangeTime Frame:
    12-16 weeks post insertion
    enhanced_encryption
    Safety Issue:
    No

Trial design

Scandinavian Mirena Insertion Nulliparous Trial of an observational study.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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