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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00307801




Registration number
NCT00307801
Ethics application status
Date submitted
27/03/2006
Date registered
28/03/2006
Date last updated
30/12/2014

Titles & IDs
Public title
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Scientific title
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.
Secondary ID [1] 0 0
2005-004340-32
Secondary ID [2] 0 0
91470
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metrorrhagia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
Treatment: Drugs - Placebo

Experimental: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) - A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 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.

Placebo comparator: Placebo - Matching placebo to be taken orally daily.


Treatment: Drugs: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
1 pill per day taken orally over 7 cycles of 28 pills per cycle

Treatment: Drugs: Placebo
1 pill per day taken orally over 7 cycles of 28 pills per cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms
Timepoint [1] 0 0
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 [1] 0 0
Proportion of Participants Cured From Prolonged Bleeding
Timepoint [1] 0 0
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 [2] 0 0
Proportion of Participants Cured From Excessive Bleeding
Timepoint [2] 0 0
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 [3] 0 0
Proportion of Participants Cured From Frequent Bleeding
Timepoint [3] 0 0
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 [4] 0 0
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84
Timepoint [4] 0 0
From baseline (visit 5, day 1) up to treatment day 84
Secondary outcome [5] 0 0
Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196
Timepoint [5] 0 0
From baseline (visit 5, day 1) up to treatment day 196
Secondary outcome [6] 0 0
Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84
Timepoint [6] 0 0
From baseline (visit 5, day 1) up to treatment day 84
Secondary outcome [7] 0 0
Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196
Timepoint [7] 0 0
From baseline (visit 5, day 1) up to treatment day 196
Secondary outcome [8] 0 0
Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Menstrual Blood Loss Volume for All Participants at Cycle 1
Timepoint [9] 0 0
Cycle 1 = 28 days (one cycle)
Secondary outcome [10] 0 0
Menstrual Blood Loss Volume for All Participants at Cycle 3
Timepoint [10] 0 0
Cycle 3 = 28 days (one cycle)
Secondary outcome [11] 0 0
Menstrual Blood Loss Volume for All Participants at Cycle 7
Timepoint [11] 0 0
Cycle 7 = 28 days (one cycle)
Secondary outcome [12] 0 0
Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.
Timepoint [13] 0 0
Cycle 1 = 28 days (one cycle)
Secondary outcome [14] 0 0
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.
Timepoint [14] 0 0
Cycle 3 = 28 days (one cycle)
Secondary outcome [15] 0 0
Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.
Timepoint [15] 0 0
Cycle 7 = 28 days (one cycle)
Secondary outcome [16] 0 0
Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment
Timepoint [17] 0 0
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
Secondary outcome [18] 0 0
Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment
Timepoint [18] 0 0
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
Secondary outcome [19] 0 0
Change From Baseline in Hemoglobin Concentration at Treatment Day 84
Timepoint [19] 0 0
Baseline (visit 5) and treatment day 84
Secondary outcome [20] 0 0
Change From Baseline in Hemoglobin Concentration at Treatment Day 196
Timepoint [20] 0 0
Baseline (visit 5) and treatment day 196
Secondary outcome [21] 0 0
Change From Baseline in Hematocrit at Treatment Day 196.
Timepoint [21] 0 0
Baseline (visit 5) and treatment day 196
Secondary outcome [22] 0 0
Change From Baseline in Ferritin Concentration at Treatment Day 84
Timepoint [22] 0 0
Baseline (visit 5, day 1) and treatment day 84
Secondary outcome [23] 0 0
Change From Baseline in Ferritin Concentration at Treatment Day 196
Timepoint [23] 0 0
Baseline (visit 5, day 1) and treatment day 196
Secondary outcome [24] 0 0
Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.
Timepoint [24] 0 0
Baseline (visit 5, day 1) and treatment day 84
Secondary outcome [25] 0 0
Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.
Timepoint [25] 0 0
Baseline (visit 5, day 1) and treatment day 196
Secondary outcome [26] 0 0
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84
Timepoint [26] 0 0
Baseline (visit 5, day 1) and treatment day 84
Secondary outcome [27] 0 0
Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196
Timepoint [27] 0 0
Baseline (visit 5, day 1) and treatment day 196
Secondary outcome [28] 0 0
Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84
Timepoint [28] 0 0
Baseline (visit 5, day 1) and treatment day 84
Secondary outcome [29] 0 0
Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196
Timepoint [29] 0 0
Baseline (visit 5, day 1) and treatment day 196
Secondary outcome [30] 0 0
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.
Timepoint [30] 0 0
Baseline (visit 5, day 1) and treatment day 84
Secondary outcome [31] 0 0
Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.
Timepoint [31] 0 0
Baseline (visit 5, day 1) and treatment day 196
Secondary outcome [32] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84.
Timepoint [32] 0 0
Treatment day 84
Secondary outcome [33] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196.
Timepoint [33] 0 0
Treatment day 196
Secondary outcome [34] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84
Timepoint [34] 0 0
Treatment day 84
Secondary outcome [35] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196
Timepoint [35] 0 0
Treatment day 196
Secondary outcome [36] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84.
Timepoint [36] 0 0
Treatment day 84
Secondary outcome [37] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196.
Timepoint [37] 0 0
Treatment day 196
Secondary outcome [38] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84
Timepoint [38] 0 0
Treatment day 84
Secondary outcome [39] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196.
Timepoint [39] 0 0
Treatment day 196
Secondary outcome [40] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84
Timepoint [40] 0 0
Treatment day 84
Secondary outcome [41] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196
Timepoint [41] 0 0
Treatment day 196
Secondary outcome [42] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit to Physician) at Treatment Day 84
Timepoint [42] 0 0
Treatment day 84
Secondary outcome [43] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit to Physician) at Treatment Day 196
Timepoint [43] 0 0
Treatment day 196
Secondary outcome [44] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84
Timepoint [44] 0 0
Treatment day 84
Secondary outcome [45] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196
Timepoint [45] 0 0
Treatment day 196
Secondary outcome [46] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84
Timepoint [46] 0 0
Treatment day 84
Secondary outcome [47] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196
Timepoint [47] 0 0
Treatment day 196
Secondary outcome [48] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (no Out-of-pocket Expenses) at Treatment Day 84
Timepoint [48] 0 0
Treatment day 84
Secondary outcome [49] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (no Out-of-pocket Expenses) at Treatment Day 196
Timepoint [49] 0 0
Treatment day 196
Secondary outcome [50] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Not Have Any Medical Treatment) at Treatment Day 84
Timepoint [50] 0 0
Treatment day 84
Secondary outcome [51] 0 0
Resource Use Assessment by Use of a Self Administered Questionnaire (Not Have Any Medical Treatment) at Treatment Day 196
Timepoint [51] 0 0
Treatment day 196

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Private Practice Dr. Ian Fraser - Ashfield
Recruitment hospital [2] 0 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
NSW 2131 - Ashfield
Recruitment postcode(s) [2] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Ceske Budejovice
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Pardubice
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Pisek
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Praha 7
Country [5] 0 0
Finland
State/province [5] 0 0
Espoo
Country [6] 0 0
Finland
State/province [6] 0 0
Lahti
Country [7] 0 0
Finland
State/province [7] 0 0
Tampere
Country [8] 0 0
Finland
State/province [8] 0 0
Turku
Country [9] 0 0
Germany
State/province [9] 0 0
Baden-Württemberg
Country [10] 0 0
Germany
State/province [10] 0 0
Niedersachsen
Country [11] 0 0
Germany
State/province [11] 0 0
Sachsen
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Komarom
Country [15] 0 0
Hungary
State/province [15] 0 0
Miskolc
Country [16] 0 0
Netherlands
State/province [16] 0 0
Enschede
Country [17] 0 0
Netherlands
State/province [17] 0 0
Geleen
Country [18] 0 0
Netherlands
State/province [18] 0 0
Nijmegen
Country [19] 0 0
Poland
State/province [19] 0 0
Bialystok
Country [20] 0 0
Poland
State/province [20] 0 0
Lodz
Country [21] 0 0
Poland
State/province [21] 0 0
Lublin
Country [22] 0 0
Poland
State/province [22] 0 0
Poznan
Country [23] 0 0
Poland
State/province [23] 0 0
Warszawa
Country [24] 0 0
Sweden
State/province [24] 0 0
Lund
Country [25] 0 0
Sweden
State/province [25] 0 0
Stockholm
Country [26] 0 0
Sweden
State/province [26] 0 0
Uppsala
Country [27] 0 0
Ukraine
State/province [27] 0 0
Kiev
Country [28] 0 0
Ukraine
State/province [28] 0 0
Lviv
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Cheshire
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Luton
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Northwood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00307801