Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00393198
First received: October 26, 2006
Last updated: October 18, 2013
Last verified: October 2013

October 26, 2006
October 18, 2013
October 2006
October 2012   (final data collection date for primary outcome measure)
Primary efficacy variable will be bleeding profile [ Time Frame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5 ] [ Designated as safety issue: Yes ]
Primary efficacy variable will be bleeding profile
Complete list of historical versions of study NCT00393198 on ClinicalTrials.gov Archive Site
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction [ Time Frame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5 ] [ Designated as safety issue: Yes ]
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
Not Provided
Not Provided
 
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia

The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.

This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Contraception
  • Menorrhagia
  • Drug: Levonorgestrel (Mirena, BAY86-5028)
    Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.
  • Drug: Cytotec
    Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
  • Drug: Placebo
    Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.
  • Experimental: Arm 1
    Intervention: Drug: Levonorgestrel (Mirena, BAY86-5028)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Cytotec
  • Active Comparator: Arm 3
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
  • Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
  • Clinically normal cervical smear result within 12 preceding months or at screening.
  • Clinically normal breast examination findings. For patients >/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.

Exclusion Criteria:

  • Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
  • Known or suspected pregnancy.
  • Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
  • Current or recurrent pelvic inflammatory disease.
  • Abnormal uterine bleeding of unknown origin.
  • Acute cervicitis or vaginitis not responding to treatment.
  • History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.
  • Any active acute liver disease or liver tumor.
Female
23 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Finland,   Sweden,   Ireland
 
NCT00393198
91473, 2006-000394-30, 309988
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP