check_circleStudy Completed

Metrorrhagia

Bayer Identifier:

91470

ClinicalTrials.gov Identifier:

NCT00307801

EudraCT Number:

2005-004340-32

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
    - 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.
  • - 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
231
Trial Dates
February 2006 - 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
Gynekologicka ambulance Vanda Horejsi, MDCeske Budejovice, 37001, Czech Republic
Completed
Adenova Lääkärikeskus OyEspoo, 02100, Finland
Completed
KoskiklinikkaTampere, 33100, Finland
Completed
Terveystalo LahtiLahti, 15110, Finland
Completed
Ylioppilaiden terveydenhoitosäätiö, TurkuTurku, 20540, Finland
Completed
emovis GmbHBerlin, 10629, Germany
Completed
ClinPharm International GmbHDresden, 01067, Germany
Completed
Praxis Hr. Dr. U. KohoutekKarlsruhe, 76199, Germany
Completed
Praxis Hr. Dr. S. SchönianRheinstetten, 76287, Germany
Completed
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Completed
Selya Janos HospitalKomarom, 2921, Hungary
Completed
University of SemmelweisBudapest, 1082, Hungary
Completed
Medisch Spectrum Twente, Locatie ArienspleinEnschede, 7511 JX, Netherlands
Completed
PreCare Trial & RecruitmentGeleen, 6166, Netherlands
Completed
Menox BVNijmegen, 6525 EC, Netherlands
Completed
CSK MSWiAWarszawa, 02-507, Poland
Completed
Center for Clinical& Basic ResearchPardubice, 2667, Czech Republic
Completed
Lekarsky dum Praha 7 a.s.Gynekologicka ambulance Dr. JenicekPraha 7, 170 00, Czech Republic
Completed
Gynekologicko-poradnicka ambulance Dr. HlavackovaPisek, 39701, Czech Republic
Completed
Borsod-Abauj-Zemplen County HospitalMiskolc, 3501, Hungary
Completed
Poliklinika Ginekologiczna- PolozniczaBialystok, 15-435, Poland
Completed
Szpital Kliniczny nr 3Poznan, 60-525, Poland
Completed
Karolinska Universitetssjukhuset HuddingeStockholm, 141 86, Sweden
Completed
Akademiska SjukhusetUppsala, SE-751 85, Sweden
Completed
Bridge House Medical CentreCheadle, SK8 5LL, United Kingdom
Completed
MeDiNova ResearchNorthwood, HA6 2RN, United Kingdom
Completed
Private Practice Dr. Ian FraserAshfield, NSW 2131, Australia
Completed
Lviv Regional Center Perinatal CenterLviv, Ukraine
Completed
Instytut Centrum Zdrowia Matki PolkiLodz, 93-338, Poland
Completed
SPSK nr 1Lublin, 20-081, Poland
Completed
Skånes UniversitetssjukhusLund, 22185, Sweden
Completed
Luton & Dunstable HospitalLuton, LU4 0DZ, United Kingdom
Completed
King Edward Memorial HospitalSubiaco, 6008, Australia
Completed
Kyiv Medical Academy of Postdyploma EducationKiev, 04210, Ukraine
Completed
Dept. of obstetrics and gynaecologyKiev, 01030, Ukraine
Completed
Instr. of Pediatrics, Obstetrics & GynecologyKiev, 04050, Ukraine

Primary Outcome

  • Proportion of participants with no dysfuntional uterine bleeding (DUB) symtoms
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Proportion of participants cured from prolonged bleeding
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants cured from excessive bleeding
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants cured from frequent bleeding
    date_rangeTime Frame:
    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
    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 (visit 5, day 1) 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 (visit 5, day 1) up to treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants with improvement in the patient’s overall assessment scale at treatment day 84
    date_rangeTime Frame:
    From baseline (visit 5, day 1) up to treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of participants with improvement in the patient’s overall assessment scale at treatment day 196
    date_rangeTime Frame:
    From baseline (visit 5, day 1) 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. 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
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for all participants at Cycle 1
    date_rangeTime Frame:
    Cycle 1 = 28 days (one cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for all participants at Cycle 3
    date_rangeTime Frame:
    Cycle 3 =28 days (one cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for all participants at Cycle 7
    date_rangeTime Frame:
    Cycle 7=28 days (one cycle)
    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. 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
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for participants with excessive bleeding at Cycle 1
    date_rangeTime Frame:
    Cycle 1=28 days (one cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for participants with excessive bleeding at Cycle 3
    date_rangeTime Frame:
    Cycle 3=28 days (one cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Menstrual blood loss volume for participants with excessive bleeding at Cycle 7
    date_rangeTime Frame:
    Cycle 7=28 days (one cycle)
    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. 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
    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. 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
    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. 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
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Hemoglobin concentration at treatment day 84
    date_rangeTime Frame:
    Baseline (visit 5) and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Hemoglobin concentration at treatment day 196
    date_rangeTime Frame:
    Baseline (visit 5) and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in hematocrit at treatment day 196
    date_rangeTime Frame:
    Baseline (visit 5) and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Ferritin concentration at treatment day 84
    date_rangeTime Frame:
    Baseline (visit 5, day 1) and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Ferritin concentration at treatment day 196
    date_rangeTime Frame:
    Baseline (visit 5, day 1) and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Psychological General Well-Being Index (PGWBI) score at treatment day 84
    date_rangeTime Frame:
    Baseline (visit 5, day 1) and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Psychological General Well-Being Index (PGWBI) score at treatment day 196
    date_rangeTime Frame:
    Baseline (visit 5, day 1) and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) score at treatment day 84
    date_rangeTime Frame:
    Baseline (visit 5, day 1) and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in McCoy Female Sexuality Questionnaire (MFSQ) score at treatment day 196
    date_rangeTime Frame:
    Baseline (visit 5, day 1) and treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in EuroQol 5 Dimensional (EQ-5D) score at treatment day 84
    date_rangeTime Frame:
    Baseline (visit 5, day 1) and treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in EuroQol 5 Dimensional (EQ-5D) score at treatment day 196
    date_rangeTime Frame:
    Baseline (visit 5, day 1) 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 (visit 5, day 1) 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 (visit 5, day 1) 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 （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 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 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 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 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 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 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 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 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 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 （unscheduled outpatient 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 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 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 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 196
    date_rangeTime Frame:
    Treatment day 196
    enhanced_encryption
    Safety Issue:
    No
  • Resource use assessment by use of a self administered questionnaire （no 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 （no 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 （not have 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 （not have any medical treatment） at treatment day 196
    date_rangeTime Frame:
    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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