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Completed

NCT Number: NCT00798980

Scandinavian Mirena Insertion Nulliparous Trial.

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.

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Key information

Conditions

Nulliparous

Age range

14 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous women Mirena insertion planned as contraceptive method

Exclusion criteria

  • 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

Treatment and study plan

Mirena (BAY86-5028)

Drug

Nulliparous Women

Primary outcomes

  1. Evaluation of the insertion procedure of Mirena in nulliparous women

    Time frame: At the insertion time point

Secondary outcomes

  1. Pain

    Time frame: At the insertion time point

  2. Continuation rate

    Time frame: 12-16 weeks post insertion

  3. Bleeding Pattern

    Time frame: 12-16 weeks post insertion

  4. Satisfaction

    Time frame: 12-16 weeks post insertion

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 27, 2008
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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