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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00293059

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)	Phase III

MedlinePlus related topics: Vaginal Bleeding

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Dienogest

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group 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

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: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of patients cured from each individual symptom, such as excessive, frequent, or prolonged bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Proportion of patients with improvement in the investigator's and patient's overall assessment scale [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment:	189
Study Start Date:	December 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1	Drug: Qlaira (BAY86-5027, SH T00658ID) 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo A blister card consists of 28 pills taken orally once a day for 28 days (one cycle)

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility

Criteria

Inclusion Criteria:

Women 18 years or older with 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 history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293059

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	91469, 308960
Study First Received:	February 15, 2006
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00293059
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Bayer:

Dysfunctional Uterine Bleeding

Study placed in the following topic categories:

Genital Diseases, Female
Metrorrhagia
Uterine Hemorrhage
Estradiol 3-benzoate
Estradiol valerate
Uterine Diseases

Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hemorrhage
Estradiol
Dienogest

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009