Phase 3 N=231 Randomized Double-blind Treatment

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Metrorrhagia

Bottom Line

View on ClinicalTrials.gov: NCT00307801 ↗

Enrolled (actual)

231

Serious AEs

1.8%

Results posted

Jul 2011

Primary outcome: Primary: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms — 0.295; 0.012 Proportion of participants — p=< 0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms	0.295; 0.012	< 0.0001 sig
SECONDARY Proportion of Participants Cured From Prolonged Bleeding	0.350; 0.100	—
SECONDARY Proportion of Participants Cured From Excessive Bleeding	0.441; 0.013	—
SECONDARY Proportion of Participants Cured From Frequent Bleeding	—	—
SECONDARY Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84	0.838; 0.394	—
SECONDARY Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196	0.847; 0.395	—
SECONDARY Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 84	0.724; 0.529	—
SECONDARY Proportion of Participants With Improvement in the Patient's Overall Assessment Scale at Treatment Day 196	0.779; 0.451	—
SECONDARY Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment	-458.4; -93.2	—
SECONDARY Menstrual Blood Loss Volume for All Participants at Cycle 1	175.6; 194.3	—
SECONDARY Menstrual Blood Loss Volume for All Participants at Cycle 3	68.3; 195.1	—
SECONDARY Menstrual Blood Loss Volume for All Participants at Cycle 7	44.6; 167.2	—
SECONDARY Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.	-480.6; -94.2	—
SECONDARY Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.	207.8; 238.9	—
SECONDARY Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.	72.1; 188.4	—
SECONDARY Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.	46.7; 168.6	—
SECONDARY Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment	-0.35; -0.38	—
SECONDARY Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment	-5.13; -3.08	—
SECONDARY Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment	-38.4; -16.5	—
SECONDARY Change From Baseline in Hemoglobin Concentration at Treatment Day 84	0.36; 0.12	—
SECONDARY Change From Baseline in Hemoglobin Concentration at Treatment Day 196	0.70; 0.06	—
SECONDARY Change From Baseline in Hematocrit at Treatment Day 196.	1.63; 0.08	—
SECONDARY Change From Baseline in Ferritin Concentration at Treatment Day 84	2.8; 0.0	—
SECONDARY Change From Baseline in Ferritin Concentration at Treatment Day 196	8.6; 0.5	—
SECONDARY Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.	-1.2; 2.2	—
SECONDARY Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.	-2.3; 4.6	—
SECONDARY Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84	-1.2; 0.4	—
SECONDARY Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196	-4.9; -2.4	—
SECONDARY Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84	-0.0041; 0.0082	—
SECONDARY Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196	-0.0191; 0.0116	—
SECONDARY Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.	-1.63; 0.62	—
SECONDARY Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.	-3.00; 2.69	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.	0.095; 0.152	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.	0.098; 0.087	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84	0.14; 0.27	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196	0.13; 0.52	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.	2.0; 3.1	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.	1.8; 3.1	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84	2.1; 3.2	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.	2.0; 3.2	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84	0.008; 0.0	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196	0.008; 0.0	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84	0.058; 0.031	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196	0.031; 0.015	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84	0.0; 0.0	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196	0.0; 0.0	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84	0.0; 0.0	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196	0.0; 0.0	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84	0.855; 0.881	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196	0.920; 0.879	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84	0.966; 0.954	—
SECONDARY Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196	0.977; 0.985	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00307801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.