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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception; Menorrhagia

Intervention: Levonorgestrel (Mirena, BAY86-5028) (Drug); Cytotec (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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

Primary outcome: Primary efficacy variable will be bleeding profile

Secondary outcome: Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction

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

Minimum age: 23 Years. Maximum age: 45 Years. Gender(s): Female.

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.

Locations and Contacts

Helsinki 00100, Finland

Hyvinkää 05800, Finland

Jyväskylä 40100, Finland

Kuopio 70110, Finland

Tampere 33100, Finland

Turku 20100, Finland

Brignoles 83170, France

Compiegne Cedex 60204, France

Nancy Cedex 54042, France

Quetigny 21800, France

Reims 51100, France

Roanne 42300, France

Drogheda, Ireland

Stockholm 118 83, Sweden

Stockholm 182 88, Sweden

Stockholm S-171 76, Sweden

Mallow, Cork, Ireland

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Starting date: October 2006
Last updated: October 31, 2014

Page last updated: August 23, 2015

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