check_circleStudy Completed

Metrorrhagia

Bayer Identifier:

91469

ClinicalTrials.gov Identifier:

NCT00293059

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 Years
  • - Women 18 years or older
    - With diagnosis of dysfunctional uterine bleeding without organic pathology
    - And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding
  • - 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.

Trial summary

Enrollment Goal
190
Trial Dates
December 2005 - May 2008
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Marin Endocrine AssociatesGreenbrae, 94904, United States
Completed
Women's Health Care, Inc.San Diego, 92123, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
Clinical Trial Center of ColoradoGreenwood Village, 80111, United States
Completed
Brown Clinic, P.L.L.P.Watertown, 57201, United States
Completed
Hawthorne Medical Research, Inc.Winston-Salem, 27103, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
Women and Child, LPPLake Havasu CIty, 86403, United States
Completed
New South MedicalClarksville, 37043, United States
Completed
South Carolina Clinical Research CenterColumbia, 29201, United States
Completed
Rapid Medical Research Inc.Cleveland, 44122, United States
Completed
Clinical Physiology Associates, Inc.Fort Myers, 33916, United States
Completed
NYU Langone Medical CenterNew York, 10016, United States
Completed
Women's Medical Research Group, LLCClearwater, 33759, United States
Completed
Women's Health PracticeChampaign, 61820, United States
Completed
Clinique de GynecologieShawinigan, G9N 2H6, Canada
Completed
Les Gynecologues AssociesMontreal, H2X 1N8, Canada
Completed
Centre d'étude clinique de Montréal Inc.Montreal, H1T 1P6, Canada
Completed
Maritimes Research CenterBathurst, E2A 4X7, Canada
Completed
National Clinical Research, Inc.Richmond, 23294, United States
Completed
Advanced Research AssociatesCorpus Christi, 78414, United States
Completed
Research Across AmericaPlano, 75093, United States
Completed
New Age Medical Research Corp.Miami, 33186, United States
Completed
South Florida Medical ResearchAventura, 33180, United States
Completed
Impact Clinical Trials - Los AngelesLos Angeles, 90010, United States
Completed
Physicians Research GroupIndianapolis, 46250, United States
Completed
Advanced Biomedical Research of AmericaLas Vegas, 89119, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Dr. John Lenihan, MDTacoma, 98405, United States
Completed
North Spokane Women's ClinicSpokane, 99207, United States
Completed
Eastern Carolina Women's CenterNew Bern, 28562, United States
Completed
Blue Hill Medical GroupPacific Palisades, 90272, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Reproductive Medical ResearchCincinnati, 45267, United States
Completed
Insignia Care for Women, P.A.Tampa, 33607, United States
Completed
Clinical Trial Center of ColoradoLittleton, 80122, United States
Completed
Womens Medical CenterBismark, 58501, United States
Completed
Obstetrical & Gynecological Associates, PAHouston, United States
Completed
Women's Health Care Group of PAPottstown, 19464, United States
Completed
Mount Vernon Clinical ResearchAtlanta, 30328, United States
Completed
Atlanta West Women's CenterDouglasville, 30134, United States
Completed
Clinique Médicale des CampusSte-Foy, G1V 4X7, Canada
Completed
Clinique Recherche en Sante des Femmes Inc.Quebec, G1S 2L6, Canada
Completed
Total Concept Health Care Inc.Kitchener, N2C 2N9, Canada
Completed
Q & T Research, Inc.Sherbrooke, J1H 4J6, Canada
Completed
Prime Health ResearchToronto, M4S 1Y2, Canada

Primary Outcome

  • Proportion of participants with no dysfunctional uterine bleeding (DUB) symptoms
    date_rangeTime Frame:
    during a time period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Proportion of participants cured from prolonged bleeding
    date_rangeTime Frame:
    during a time period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants cured from frequent bleeding
    date_rangeTime Frame:
    during a time period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants cured from excessive bleeding
    date_rangeTime Frame:
    during a time period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants with improvement in the investigator’s global assessment scale at treatment day 84
    date_rangeTime Frame:
    from baseline up to treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants with improvement in the investigator’s global assessment scale at treatment day 196
    date_rangeTime Frame:
    from baseline up to treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants with improvement in the participant’s overall assessment scale at treatment day 84
    date_rangeTime Frame:
    from baseline up to treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants with improvement in the participant’s overall assessment scale at treatment day 196
    date_rangeTime Frame:
    from baseline up to treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in blood loss volume for all participants to the reference period of 90 days under treatment
    date_rangeTime Frame:
    Baseline and reference period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for all participants at Cycle 1
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for all participants at Cycle 3
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for all participants at Cycle 7
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in blood loss volume for participants with excessive bleeding to the reference period of 90 days under treatment
    date_rangeTime Frame:
    baseline and reference period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for participants with excessive bleeding at Cycle 1
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for participants with excessive bleeding at Cycle 3
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for participants with excessive bleeding at Cycle 7
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in number of bleeding days to the reference period of 90 days under treatment
    date_rangeTime Frame:
    baseline and reference period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in number of bleeding episodes to the reference period of 90 days under treatment
    date_rangeTime Frame:
    baseline and reference period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in number of sanitary protection used at 90 days of treatment
    date_rangeTime Frame:
    baseline and reference period of 90 days under treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Psychological General Well-Being Index (PGWBI) scores at treatment day 84
    date_rangeTime Frame:
    baseline and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Psychological General Well-Being Index (PGWBI) scores at treatment day 196
    date_rangeTime Frame:
    baseline and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) scores at treatment day 84
    date_rangeTime Frame:
    baseline and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) scores at treatment day 196
    date_rangeTime Frame:
    baseline and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in EuroQoL (quality of life) 5 Dimensional health questionnaire (EQ-5D) scores at treatment day 84
    date_rangeTime Frame:
    baseline and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in EuroQoL (quality of life) 5 Dimensional health questionnaire (EQ-5D) scores at treatment day 196
    date_rangeTime Frame:
    baseline and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Visual Analogue Scale (VAS) of the EQ-5D score at treatment day 84
    date_rangeTime Frame:
    baseline and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Visual Analogue Scale (VAS) of the EQ-5D score at treatment day 196
    date_rangeTime Frame:
    baseline and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (change in the employment status) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (days missed from work) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (productivity while working) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (regular daily activities) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (unscheduled outpatient visit at hospital) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (unscheduled visit to physician) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (additional unscheduled procedures) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (received ambulatory services) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (out-of-pocket expenses) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (any medical treatment) at treatment day 84
    date_rangeTime Frame:
    treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (change in the employment status) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (days missed from work) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (productivity while working) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (regular daily activities) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (unscheduled outpatient visit at hospital) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (unscheduled visit to physician) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (additional unscheduled procedures) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (received ambulatory services) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (out-of-pocket expenses) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire (any medical treatment) at treatment day 196
    date_rangeTime Frame:
    treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Hematocrit (Hct) concentrations at treatment day 196
    date_rangeTime Frame:
    baseline and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in serum ferritin concentration at treatment day 84
    date_rangeTime Frame:
    baseline and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in serum ferritin concentration at treatment day 196
    date_rangeTime Frame:
    baseline and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in hemoglobin concentration at treatment day 84
    date_rangeTime Frame:
    baseline and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in hemoglobin concentration at treatment day 196
    date_rangeTime Frame:
    baseline and treatment day 196
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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