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Clinical Trials/NCT01958684
NCT01958684
Completed
Not Applicable

A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD

Bayer0 sites512 target enrollmentOctober 2013
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ConditionsContraception
InterventionsLevonorgestrel IUS (Mirena, BAY86-5028)Copper-IUD
DrugsLevonorgestrel IUS (Mirena, BAY86-5028)

Overview

Phase
Not Applicable
Intervention
Levonorgestrel IUS (Mirena, BAY86-5028)
Conditions
Contraception
Sponsor
Bayer
Enrollment
512
Primary Endpoint
The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
October 2014
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Bayer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Reproductive women in good general health and requesting long-term contraception
  • •Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion
  • •History of regular cyclic menstrual periods
  • •Written ICF was obtained

Exclusion Criteria

  • •Suspected septic abortion and incomplete abortion, as well as missed abortion
  • •The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed

Arms & Interventions

Group 1

The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h)

Intervention: Levonorgestrel IUS (Mirena, BAY86-5028)

Group 2

Copper IUDs with different shape and with or without drugs

Intervention: Copper-IUD

Outcomes

Primary Outcomes

The number of bleeding/spotting days assessed over the second 90-day reference period after induced abortion

Time Frame: Months 4 to 6

The 90-day reference period is recommended by the WHO. Day 1 is defined as the insertion day.

Secondary Outcomes

  • Menstrual bleeding intensity(up to 6 months)
  • Abortion related bleeding days(up to 1 month)
  • Reasons for discontinuation of Mirena and Cu-IUD(Up to 6 months)
  • Time to the first menstrual bleeding following abortion(up to 2 months)
  • Participants continuation rates of Mirena and Cu-IUD(up to 6 months)
  • Percentage of participants with adverse events(Up to 6 months)
  • Participants satisfaction rates of Mirena and Cu-IUD(Up to 6 months)

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