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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393198
• Other study ID #: 91473
• Secondary ID: 2006-000394-3030
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2006
• Last updated: October 31, 2014
• Start date: October 2006
• Est. completion date: October 2012

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Ireland: Irish Medicines BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception
• Menorrhagia

Intervention

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.
• Cytotec
Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
• Placebo
Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Finland,  France,  Ireland,  Sweden, 

References & Publications (3)

Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: — View Citation

Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8. — View Citation

Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauter — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy variable will be bleeding profile		Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5	Yes
Secondary	Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction		Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5	Yes

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