Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00393198
First received: October 26, 2006
Last updated: November 28, 2012
Last verified: November 2012
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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: | 205 |
| 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
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: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00393198 History of Changes |
| Other Study ID Numbers: | 91473, 2006-000394-30, 309988 |
| Study First Received: | October 26, 2006 |
| Last Updated: | November 28, 2012 |
| 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:
|
Hemorrhage Menorrhagia Pathologic Processes Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances Levonorgestrel Misoprostol Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013