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Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

NCT ID: NCT00307801

Last Updated: 2014-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-05-31

Brief Summary

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

Detailed Description

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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Conditions

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Metrorrhagia

Keywords

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Dysfunctional uterine bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)

Intervention Type DRUG

1 pill per day taken orally over 7 cycles of 28 pills per cycle

Placebo

Matching placebo to be taken orally daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 pill per day taken orally over 7 cycles of 28 pills per cycle

Interventions

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Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)

1 pill per day taken orally over 7 cycles of 28 pills per cycle

Intervention Type DRUG

Placebo

1 pill per day taken orally over 7 cycles of 28 pills per cycle

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Private Practice Dr. Ian Fraser

Ashfield, New South Wales, Australia

Site Status

King Edward Memorial Hospital

Subiaco, Western Australia, Australia

Site Status

Gynekologicka ambulance Vanda Horejsi, MD

České Budějovice, , Czechia

Site Status

Center for Clinical& Basic Research

Pardubice, , Czechia

Site Status

Gynekologicko-poradnicka ambulance Dr. Hlavackova

Písek, , Czechia

Site Status

Lekarsky dum Praha 7 a.s.Gynekologicka ambulance Dr. Jenicek

Prague, , Czechia

Site Status

Adenova Lääkärikeskus Oy

Espoo, , Finland

Site Status

Terveystalo Lahti

Lahti, , Finland

Site Status

Koskiklinikka

Tampere, , Finland

Site Status

Ylioppilaiden terveydenhoitosäätiö, Turku

Turku, , Finland

Site Status

Praxis Hr. Dr. U. Kohoutek

Karlsruhe, Baden-Wurttemberg, Germany

Site Status

Praxis Hr. Dr. S. Schönian

Rheinstetten, Baden-Wurttemberg, Germany

Site Status

Praxis Hr. Dr. K. Greven

Hanover, Lower Saxony, Germany

Site Status

ClinPharm International GmbH

Dresden, Saxony, Germany

Site Status

emovis GmbH

Berlin, State of Berlin, Germany

Site Status

University of Semmelweis

Budapest, , Hungary

Site Status

Selya Janos Hospital

Komárom, , Hungary

Site Status

Borsod-Abauj-Zemplen County Hospital

Miskolc, , Hungary

Site Status

Medisch Spectrum Twente, Locatie Ariensplein

Enschede, , Netherlands

Site Status

PreCare Trial & Recruitment

Geleen, , Netherlands

Site Status

Menox BV

Nijmegen, , Netherlands

Site Status

Poliklinika Ginekologiczna- Poloznicza

Bialystok, , Poland

Site Status

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Site Status

SPSK nr 1

Lublin, , Poland

Site Status

Szpital Kliniczny nr 3

Poznan, , Poland

Site Status

CSK MSWiA

Warsaw, , Poland

Site Status

Skånes Universitetssjukhus

Lund, , Sweden

Site Status

Karolinska Universitetssjukhuset Huddinge

Stockholm, , Sweden

Site Status

Akademiska Sjukhuset

Uppsala, , Sweden

Site Status

Dept. of obstetrics and gynaecology

Kiev, , Ukraine

Site Status

Instr. of Pediatrics, Obstetrics & Gynecology

Kiev, , Ukraine

Site Status

Kyiv Medical Academy of Postdyploma Education

Kiev, , Ukraine

Site Status

Lviv Regional Center Perinatal Center

Lviv, , Ukraine

Site Status

Bridge House Medical Centre

Cheadle, Cheshire, United Kingdom

Site Status

Luton & Dunstable Hospital

Luton, , United Kingdom

Site Status

MeDiNova Research

Northwood, , United Kingdom

Site Status

Countries

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Australia Czechia Finland Germany Hungary Netherlands Poland Sweden Ukraine United Kingdom

References

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Fraser IS, Jensen J, Schaefers M, Mellinger U, Parke S, Serrani M. Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest. Contraception. 2012 Aug;86(2):96-101. doi: 10.1016/j.contraception.2011.11.011. Epub 2012 Jan 10.

Reference Type RESULT
PMID: 22240178 (View on PubMed)

Fraser IS, Parke S, Mellinger U, Machlitt A, Serrani M, Jensen J. Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest. Eur J Contracept Reprod Health Care. 2011 Aug;16(4):258-69. doi: 10.3109/13625187.2011.591456.

Reference Type RESULT
PMID: 21774563 (View on PubMed)

Fraser IS, Romer T, Parke S, Zeun S, Mellinger U, Machlitt A, Jensen JT. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Hum Reprod. 2011 Oct;26(10):2698-708. doi: 10.1093/humrep/der224. Epub 2011 Jul 21.

Reference Type RESULT
PMID: 21784734 (View on PubMed)

Wasiak R, Filonenko A, Vanness DJ, Wittrup-Jensen KU, Stull DE, Siak S, Fraser I. Impact of estradiol-valerate/dienogest on work productivity and activities of daily living in European and Australian women with heavy menstrual bleeding. Int J Womens Health. 2012;4:271-8. doi: 10.2147/IJWH.S31740. Epub 2012 Jul 12.

Reference Type RESULT
PMID: 22927764 (View on PubMed)

Fraser IS, Zeun S, Parke S, Wilke B, Junge W, Serrani M. Improving the objective quality of large-scale clinical trials for women with heavy menstrual bleeding: experience from 2 multi-center, randomized trials. Reprod Sci. 2013 Jul;20(7):745-54. doi: 10.1177/1933719113477492. Epub 2013 Feb 25.

Reference Type RESULT
PMID: 23439617 (View on PubMed)

Related Links

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http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

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2005-004340-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

308961

Identifier Type: OTHER

Identifier Source: secondary_id

91470

Identifier Type: -

Identifier Source: org_study_id