Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00307801

Purpose

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Condition	Intervention	Phase
Metrorrhagia	Drug: Qlaira (BAY86-5027, SH T00658ID) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, 7 Cycle Duration of Oral SH T00658ID Tablets for the Treatment of Dysfunctional Uterine Bleeding

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Bleeding

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Proportion of patients with no dysfunctional uterine bleeding symptoms during the 90-day reference period [ Time Frame: daily measurement over 28 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients cured from each individual symptom, such as excessive, frequent or prolonged bleeding [ Time Frame: daily measurement during 28 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	575
Study Start Date:	February 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Qlaira (BAY86-5027, SH T00658ID) 1 pill per day taken orally over 7 cycles of 28 pills per cycle
Arm 2: Placebo Comparator	Drug: Placebo 1 pill per day taken orally over 7 cycles of 28 pills per cycle

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany 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:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women 18 years or older with a diagnosis of dysfunctional uterine bleeding with at least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria:

The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study. Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307801

Show 36 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91470, EudraCT: 2005-004340-32, 308961
Study First Received:	March 27, 2006
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00307801 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Finland: National Agency for Medicines; Hungary: National Institute of Pharmacy; Poland: Ministry of Health; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration

Keywords provided by Bayer:

Dysfunctional uterine bleeding

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Hemorrhage
Metrorrhagia
Uterine Diseases
Hemorrhage

Additional relevant MeSH terms:

Genital Diseases, Female
Pathologic Processes
Uterine Hemorrhage

Metrorrhagia
Uterine Diseases
Hemorrhage

ClinicalTrials.gov processed this record on September 11, 2009