Trial Condition(s):
Metrorrhagia
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Bayer Identifier:
91469
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Marin Endocrine Associates Greenbrae, United States, 94904 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Care, Inc. San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trial Center of Colorado Greenwood Village, United States, 80111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brown Clinic, P.L.L.P. Watertown, United States, 57201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hawthorne Medical Research, Inc. Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Health and Science University Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women and Child, LPP Lake Havasu CIty, United States, 86403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New South Medical Clarksville, United States, 37043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Carolina Clinical Research Center Columbia, United States, 29201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rapid Medical Research Inc. Cleveland, United States, 44122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Physiology Associates, Inc. Fort Myers, United States, 33916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NYU Langone Medical Center New York, United States, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Practice Champaign, United States, 61820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique de Gynecologie Shawinigan, Canada, G9N 2H6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Les Gynecologues Associes Montreal, Canada, H2X 1N8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'étude clinique de Montréal Inc. Montreal, Canada, H1T 1P6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maritimes Research Center Bathurst, Canada, E2A 4X7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Clinical Research, Inc. Richmond, United States, 23294 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Research Associates Corpus Christi, United States, 78414 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Across America Plano, United States, 75093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Age Medical Research Corp. Miami, United States, 33186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Florida Medical Research Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Impact Clinical Trials - Los Angeles Los Angeles, United States, 90010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Physicians Research Group Indianapolis, United States, 46250 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Biomedical Research of America Las Vegas, United States, 89119 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. John Lenihan, MD Tacoma, United States, 98405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Spokane Women's Clinic Spokane, United States, 99207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eastern Carolina Women's Center New Bern, United States, 28562 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Blue Hill Medical Group Pacific Palisades, United States, 90272 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Reproductive Medical Research Cincinnati, United States, 45267 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Insignia Care for Women, P.A. Tampa, United States, 33607 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trial Center of Colorado Littleton, United States, 80122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Womens Medical Center Bismark, United States, 58501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Obstetrical & Gynecological Associates, PA Houston, United States | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Care Group of PA Pottstown, United States, 19464 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Clinical Research Atlanta, United States, 30328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atlanta West Women's Center Douglasville, United States, 30134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Médicale des Campus Ste-Foy, Canada, G1V 4X7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Recherche en Sante des Femmes Inc. Quebec, Canada, G1S 2L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Total Concept Health Care Inc. Kitchener, Canada, N2C 2N9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Q & T Research, Inc. Sherbrooke, Canada, J1H 4J6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prime Health Research Toronto, Canada, M4S 1Y2 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Proportion of participants with no dysfunctional uterine bleeding (DUB) symptomsTimeframe: during a time period of 90 days under treatment
Secondary Outcome
- Proportion of participants cured from prolonged bleedingTimeframe: during a time period of 90 days under treatment
- Proportion of participants cured from frequent bleedingTimeframe: during a time period of 90 days under treatment
- Proportion of participants cured from excessive bleedingTimeframe: during a time period of 90 days under treatment
- Proportion of participants with improvement in the investigator’s global assessment scale at treatment day 84Timeframe: from baseline up to treatment day 84
- Proportion of participants with improvement in the investigator’s global assessment scale at treatment day 196Timeframe: from baseline up to treatment day 196
- Proportion of participants with improvement in the participant’s overall assessment scale at treatment day 84Timeframe: from baseline up to treatment day 84
- Proportion of participants with improvement in the participant’s overall assessment scale at treatment day 196Timeframe: from baseline up to treatment day 196
- Change from baseline in blood loss volume for all participants to the reference period of 90 days under treatmentTimeframe: Baseline and reference period of 90 days under treatment
- Menstrual blood loss volume for all participants at Cycle 1Timeframe: 28 days
- Menstrual blood loss volume for all participants at Cycle 3Timeframe: 28 days
- Menstrual blood loss volume for all participants at Cycle 7Timeframe: 28 days
- Change from baseline in blood loss volume for participants with excessive bleeding to the reference period of 90 days under treatmentTimeframe: baseline and reference period of 90 days under treatment
- Menstrual blood loss volume for participants with excessive bleeding at Cycle 1Timeframe: 28 days
- Menstrual blood loss volume for participants with excessive bleeding at Cycle 3Timeframe: 28 days
- Menstrual blood loss volume for participants with excessive bleeding at Cycle 7Timeframe: 28 days
- Change from baseline in number of bleeding days to the reference period of 90 days under treatmentTimeframe: baseline and reference period of 90 days under treatment
- Change from baseline in number of bleeding episodes to the reference period of 90 days under treatmentTimeframe: baseline and reference period of 90 days under treatment
- Change from baseline in number of sanitary protection used at 90 days of treatmentTimeframe: baseline and reference period of 90 days under treatment
- Change from baseline in Psychological General Well-Being Index (PGWBI) scores at treatment day 84Timeframe: baseline and treatment day 84
- Change from baseline in Psychological General Well-Being Index (PGWBI) scores at treatment day 196Timeframe: baseline and treatment day 196
- Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) scores at treatment day 84Timeframe: baseline and treatment day 84
- Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) scores at treatment day 196Timeframe: baseline and treatment day 196
- Change from baseline in EuroQoL (quality of life) 5 Dimensional health questionnaire (EQ-5D) scores at treatment day 84Timeframe: baseline and treatment day 84
- Change from baseline in EuroQoL (quality of life) 5 Dimensional health questionnaire (EQ-5D) scores at treatment day 196Timeframe: baseline and treatment day 196
- Change from baseline in Visual Analogue Scale (VAS) of the EQ-5D score at treatment day 84Timeframe: baseline and treatment day 84
- Change from baseline in Visual Analogue Scale (VAS) of the EQ-5D score at treatment day 196Timeframe: baseline and treatment day 196
- Resource use assessment by use of a self administered questionnaire (change in the employment status) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (days missed from work) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (productivity while working) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (regular daily activities) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (unscheduled outpatient visit at hospital) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (unscheduled visit to physician) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (additional unscheduled procedures) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (received ambulatory services) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (out-of-pocket expenses) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (any medical treatment) at treatment day 84Timeframe: treatment day 84
- Resource use assessment by use of a self administered questionnaire (change in the employment status) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (days missed from work) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (productivity while working) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (regular daily activities) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (unscheduled outpatient visit at hospital) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (unscheduled visit to physician) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (additional unscheduled procedures) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (received ambulatory services) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (out-of-pocket expenses) at treatment day 196Timeframe: treatment day 196
- Resource use assessment by use of a self administered questionnaire (any medical treatment) at treatment day 196Timeframe: treatment day 196
- Change from baseline in Hematocrit (Hct) concentrations at treatment day 196Timeframe: baseline and treatment day 196
- Change from baseline in serum ferritin concentration at treatment day 84Timeframe: baseline and treatment day 84
- Change from baseline in serum ferritin concentration at treatment day 196Timeframe: baseline and treatment day 196
- Change from baseline in hemoglobin concentration at treatment day 84Timeframe: baseline and treatment day 84
- Change from baseline in hemoglobin concentration at treatment day 196Timeframe: baseline and treatment day 196
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