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
  Purpose

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 Intervention Phase
Contraception
Menorrhagia
Drug: Levonorgestrel (Mirena, BAY86-5028)
Drug: Cytotec
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 204
Study Start Date: October 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   23 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393198

Locations
Finland
Helsinki, Finland, 00100
Hyvinkää, Finland, 05800
Jyväskylä, Finland, 40100
Kuopio, Finland, 70110
Tampere, Finland, 33100
Turku, Finland, 20100
France
Brignoles, France, 83170
Compiegne Cedex, France, 60204
Nancy Cedex, France, 54042
Quetigny, France, 21800
Reims, France, 51100
Roanne, France, 42300
Ireland
Mallow, Cork, Ireland
Drogheda, Ireland
Sweden
Stockholm, Sweden, S-171 76
Stockholm, Sweden, 118 83
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00393198     History of Changes
Other Study ID Numbers: 91473, 2006-000394-30, 309988
Study First Received: October 26, 2006
Last Updated: October 18, 2013
Health Authority: Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Sweden: Medical Products Agency

Keywords provided by Bayer:
Intrauterine System
Contraception
Menorrhagia

Additional relevant MeSH terms:
Menorrhagia
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage
Levonorgestrel
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014