Trial Condition(s):
Metrorrhagia
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Bayer Identifier:
91470
ClinicalTrials.gov Identifier:
EudraCT Number:
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 - And with a 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 a history of endometrial ablation or dilatation and 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 | Status | |
|---|---|---|
Locations Gynekologicka ambulance Vanda Horejsi, MD Ceske Budejovice, Czech Republic, 37001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Adenova Lääkärikeskus Oy Espoo, Finland, 02100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Koskiklinikka Tampere, Finland, 33100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Terveystalo Lahti Lahti, Finland, 15110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ylioppilaiden terveydenhoitosäätiö, Turku Turku, Finland, 20540 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations emovis GmbH Berlin, Germany, 10629 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ClinPharm International GmbH Dresden, Germany, 01067 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. U. Kohoutek Karlsruhe, Germany, 76199 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. S. Schönian Rheinstetten, Germany, 76287 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Greven Hannover, Germany, 30459 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Selya Janos Hospital Komarom, Hungary, 2921 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Semmelweis Budapest, Hungary, 1082 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Spectrum Twente, Locatie Ariensplein Enschede, Netherlands, 7511 JX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PreCare Trial & Recruitment Geleen, Netherlands, 6166 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Menox BV Nijmegen, Netherlands, 6525 EC | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CSK MSWiA Warszawa, Poland, 02-507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Clinical& Basic Research Pardubice, Czech Republic, 2667 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lekarsky dum Praha 7 a.s.Gynekologicka ambulance Dr. Jenicek Praha 7, Czech Republic, 170 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gynekologicko-poradnicka ambulance Dr. Hlavackova Pisek, Czech Republic, 39701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Borsod-Abauj-Zemplen County Hospital Miskolc, Hungary, 3501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Poliklinika Ginekologiczna- Poloznicza Bialystok, Poland, 15-435 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Kliniczny nr 3 Poznan, Poland, 60-525 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset Huddinge Stockholm, Sweden, 141 86 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska Sjukhuset Uppsala, Sweden, SE-751 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bridge House Medical Centre Cheadle, United Kingdom, SK8 5LL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MeDiNova Research Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Private Practice Dr. Ian Fraser Ashfield, Australia, NSW 2131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lviv Regional Center Perinatal Center Lviv, Ukraine | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instytut Centrum Zdrowia Matki Polki Lodz, Poland, 93-338 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SPSK nr 1 Lublin, Poland, 20-081 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skånes Universitetssjukhus Lund, Sweden, 22185 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Luton & Dunstable Hospital Luton, United Kingdom, LU4 0DZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations King Edward Memorial Hospital Subiaco, Australia, 6008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyiv Medical Academy of Postdyploma Education Kiev, Ukraine, 04210 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dept. of obstetrics and gynaecology Kiev, Ukraine, 01030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instr. of Pediatrics, Obstetrics & Gynecology Kiev, Ukraine, 04050 | Status Completed | 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 dysfuntional uterine bleeding (DUB) symtomsTimeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
Secondary Outcome
- Proportion of participants cured from prolonged bleedingTimeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- Proportion of participants cured from excessive bleedingTimeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- Proportion of participants cured from frequent bleedingTimeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- Proportion of participants with improvement in the investigator’s global assessment scale at treatment day 84Timeframe: From baseline (visit 5, day 1) up to treatment day 84
- Proportion of participants with improvement in the investigator’s global assessment scale at treatment day 196Timeframe: From baseline (visit 5, day 1) up to treatment day 196
- Proportion of participants with improvement in the patient’s overall assessment scale at treatment day 84Timeframe: From baseline (visit 5, day 1) up to treatment day 84
- Proportion of participants with improvement in the patient’s overall assessment scale at treatment day 196Timeframe: From baseline (visit 5, day 1) 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. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- Menstrual blood loss volume for all participants at Cycle 1Timeframe: Cycle 1 = 28 days (one cycle)
- Menstrual blood loss volume for all participants at Cycle 3Timeframe: Cycle 3 =28 days (one cycle)
- Menstrual blood loss volume for all participants at Cycle 7Timeframe: Cycle 7=28 days (one cycle)
- 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. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- Menstrual blood loss volume for participants with excessive bleeding at Cycle 1Timeframe: Cycle 1=28 days (one cycle)
- Menstrual blood loss volume for participants with excessive bleeding at Cycle 3Timeframe: Cycle 3=28 days (one cycle)
- Menstrual blood loss volume for participants with excessive bleeding at Cycle 7Timeframe: Cycle 7=28 days (one cycle)
- 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. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- 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. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- Change from baseline in number of sanitary protection used at 90 days of treatmentTimeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
- Change from baseline in Hemoglobin concentration at treatment day 84Timeframe: Baseline (visit 5) and treatment day 84
- Change from baseline in Hemoglobin concentration at treatment day 196Timeframe: Baseline (visit 5) and treatment day 196
- Change from baseline in hematocrit at treatment day 196Timeframe: Baseline (visit 5) and treatment day 196
- Change from baseline in Ferritin concentration at treatment day 84Timeframe: Baseline (visit 5, day 1) and treatment day 84
- Change from baseline in Ferritin concentration at treatment day 196Timeframe: Baseline (visit 5, day 1) and treatment day 196
- Change from baseline in Psychological General Well-Being Index (PGWBI) score at treatment day 84Timeframe: Baseline (visit 5, day 1) and treatment day 84
- Change from baseline in Psychological General Well-Being Index (PGWBI) score at treatment day 196Timeframe: Baseline (visit 5, day 1) and treatment day 196
- Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) score at treatment day 84Timeframe: Baseline (visit 5, day 1) and treatment day 84
- Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) score at treatment day 196Timeframe: Baseline (visit 5, day 1) and treatment day 196
- Change from baseline in EuroQol 5 Dimensional (EQ-5D) score at treatment day 84Timeframe: Baseline (visit 5, day 1) and treatment day 84
- Change from baseline in EuroQol 5 Dimensional (EQ-5D) score at treatment day 196Timeframe: Baseline (visit 5, day 1) and treatment day 196
- Change from baseline in Visual Analogue Scale (VAS) of the EQ-5D score at treatment day 84Timeframe: Baseline (visit 5, day 1) and treatment day 84
- Change from baseline in Visual Analogue Scale (VAS) of the EQ-5D score at treatment day 196Timeframe: Baseline (visit 5, day 1) 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 （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 84Timeframe: Treatment day 84
- 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 84Timeframe: Treatment day 84
- 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 84Timeframe: Treatment day 84
- 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 84Timeframe: Treatment day 84
- 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 outpatient visit to physician） at treatment day 84Timeframe: Treatment day 84
- Resource use assessment by use of a self administered questionnaire （unscheduled outpatient 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 84Timeframe: Treatment day 84
- 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 84Timeframe: Treatment day 84
- 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 （no out-of-pocket expenses） at treatment day 84Timeframe: Treatment day 84
- Resource use assessment by use of a self administered questionnaire （no out-of-pocket expenses） at treatment day 196Timeframe: Treatment day 196
- Resource use assessment by use of a self administered questionnaire （not have any medical treatment） at treatment day 84Timeframe: Treatment day 84
- Resource use assessment by use of a self administered questionnaire （not have any medical treatment） at treatment day 196Timeframe: Treatment day 196
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