We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00393198
Recruitment Status : Completed
First Posted : October 27, 2006
Last Update Posted : November 2, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Menorrhagia Drug: Levonorgestrel (Mirena, BAY86-5028) Drug: Cytotec Drug: Placebo Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia
Study Start Date : October 2006
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 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.

Placebo Comparator: Arm 2 Drug: Cytotec
Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit

Active Comparator: Arm 3 Drug: Placebo
Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393198

Layout table for location information
Helsinki, Finland, 00100
Hyvinkää, Finland, 05800
Jyväskylä, Finland, 40100
Kuopio, Finland, 70110
Tampere, Finland, 33100
Turku, Finland, 20100
Brignoles, France, 83170
Compiegne Cedex, France, 60204
Nancy Cedex, France, 54042
Quetigny, France, 21800
Reims, France, 51100
Roanne, France, 42300
Mallow, Cork, Ireland
Drogheda, Ireland
Stockholm, Sweden, 118 83
Stockholm, Sweden, 182 88
Stockholm, Sweden, S-171 76
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00393198    
Other Study ID Numbers: 91473
2006-000394-30 ( EudraCT Number )
309988 ( Other Identifier: Company internal )
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: November 2, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Intrauterine System
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents