Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

NCT00307801 | Completed Phase 3 Results

• 3 other identifiers: 914702005-004340-32308961
• Study Type: interventional
• Target: 231
• Locations: 10 countries
• Sites: 36

Brief Summary

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

Conditions

Metrorrhagia

Keywords

Dysfunctional uterine bleeding

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms

  At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) \>7 days, no \>4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no \>1 BE increase from baseline, no increase from baseline in individual patient's total number of bleeding days and total number of bleeding days not \>24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in.

  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 Outcomes (51)

• Proportion of Participants Cured From Prolonged Bleeding

  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 Bleeding

  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 Bleeding

  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 84

  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 196

  From baseline (visit 5, day 1) up to treatment day 196

Study Arms (2)

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

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

Matching placebo to be taken orally daily.

Drug: Placebo

Interventions

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

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

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

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (36)

Private Practice Dr. Ian Fraser

Ashfield, New South Wales, NSW 2131, Australia

Location

King Edward Memorial Hospital

Subiaco, Western Australia, 6008, Australia

Location

Gynekologicka ambulance Vanda Horejsi, MD

České Budějovice, 37001, Czechia

Location

Center for Clinical& Basic Research

Pardubice, 2667, Czechia

Location

Gynekologicko-poradnicka ambulance Dr. Hlavackova

Písek, 39701, Czechia

Location

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

Prague, 170 00, Czechia

Location

Adenova Lääkärikeskus Oy

Espoo, 02100, Finland

Location

Terveystalo Lahti

Lahti, 15110, Finland

Location

Koskiklinikka

Tampere, 33100, Finland

Location

Ylioppilaiden terveydenhoitosäätiö, Turku

Turku, 20540, Finland

Location

Praxis Hr. Dr. U. Kohoutek

Karlsruhe, Baden-Wurttemberg, 76199, Germany

Location

Praxis Hr. Dr. S. Schönian

Rheinstetten, Baden-Wurttemberg, 76287, Germany

Location

Praxis Hr. Dr. K. Greven

Hanover, Lower Saxony, 30459, Germany

Location

ClinPharm International GmbH

Dresden, Saxony, 01067, Germany

Location

emovis GmbH

Berlin, State of Berlin, 10629, Germany

Location

University of Semmelweis

Budapest, 1082, Hungary

Location

Selya Janos Hospital

Komárom, 2921, Hungary

Location

Borsod-Abauj-Zemplen County Hospital

Miskolc, 3501, Hungary

Location

Medisch Spectrum Twente, Locatie Ariensplein

Enschede, 7511 JX, Netherlands

Location

PreCare Trial & Recruitment

Geleen, 6166, Netherlands

Location

Menox BV

Nijmegen, 6525 EC, Netherlands

Location

Poliklinika Ginekologiczna- Poloznicza

Bialystok, 15-435, Poland

Location

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

Location

SPSK nr 1

Lublin, 20-081, Poland

Location

Szpital Kliniczny nr 3

Poznan, 60-525, Poland

Location

CSK MSWiA

Warsaw, 02-507, Poland

Location

Skånes Universitetssjukhus

Lund, 22185, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, 141 86, Sweden

Location

Akademiska Sjukhuset

Uppsala, SE-751 85, Sweden

Location

Dept. of obstetrics and gynaecology

Kiev, 01030, Ukraine

Location

Instr. of Pediatrics, Obstetrics & Gynecology

Kiev, 04050, Ukraine

Location

Kyiv Medical Academy of Postdyploma Education

Kiev, 04210, Ukraine

Location

Lviv Regional Center Perinatal Center

Lviv, Ukraine

Location

Bridge House Medical Centre

Cheadle, Cheshire, SK8 5LL, United Kingdom

Location

Luton & Dunstable Hospital

Luton, LU4 0DZ, United Kingdom

Location

MeDiNova Research

Northwood, HA6 2RN, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 22240178 RESULT

• 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.

  PMID: 21774563 RESULT

• 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.

  PMID: 21784734 RESULT

• 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.

  PMID: 22927764 RESULT

• 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.

  PMID: 23439617 RESULT

Related Links

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

MeSH Terms

Conditions

Metrorrhagia

Interventions

Estradiol; dienogest

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 28, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 30, 2014
• Results First Posted: July 29, 2011

Record last verified: 2014-12

Locations

CZ (4); NL (3); AU (2); HU (3); GB (3); DE (5); FI (4); PL (5); SE (3); UA (4)