NCT00185367

Brief Summary

The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
798

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2005

Geographic Reach
3 countries

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 15, 2011

Status Verified

July 1, 2011

First QC Date

September 13, 2005

Last Update Submit

July 14, 2011

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

  • Bleeding pattern

    7 treatment cycles each consisting of 28 days

  • Number of unintended pregnancies

    7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcomes (1)

  • Adverse event collection

    7 treatment cycles each consisting of 28 days and follow-up period of 14 days

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Arm 2

ACTIVE COMPARATOR
Drug: SH D 593 B (Miranova)

Interventions

EV/DNG (Qlaira, BAY86-5027, SH T00658K)DRUG

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo

Arm 1
SH D 593 B (Miranova)DRUG

7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo

Arm 2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female volunteers aged between 18 and 50 years requiring contraception

You may not qualify if:

  • Pregnancy or lactation
  • Any conditions that might interfere with the outcome as well as all contraindications for OC use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Soukroma gynekologicka ambulance

Fulnek, 74245, Czechia

Location

Soukroma gynekologicka ambulance

Pilsen, 30708, Czechia

Location

Provozorna Gynekologicka ordinace Dr. Tesar

Prague, 109 00, Czechia

Location

Femina Sana s.r.o

Prague, 13000, Czechia

Location

Soukroma gynekologicka ambulance

Zábřeh nad Odrou, 70400, Czechia

Location

Dr. Jocelyne Nataf-Maurin

Brignoles, 83170, France

Location

Dr. Marie-Helene Malbranche-Aupecle

Dijon, 21000, France

Location

Centre Hospitalier de l Estuaire

Honfleur, 14601, France

Location

Dr. Annette Mercier

Morlaix, 29600, France

Location

Clinique d Occitanie

Muret, 31600, France

Location

Centre Medical du Val de Loire

Nevers, 58000, France

Location

Dr. Anne-Isabelle Richet

Paris, 75007, France

Location

Cabinet medical

Quetigny, 21800, France

Location

Dr. Gwendoline Servan

Tarare, 69170, France

Location

Dr. Aliette Siboni-Frisch

Toulouse, 31000, France

Location

Frauenarztpraxis Dr. Buchberger

Neubiberg, Bavaria, 85579, Germany

Location

Praxis Hr. Dr. R. Kuett

Nuremberg, Bavaria, 90491, Germany

Location

Praxis Dr. Larbig

Fulda, Hesse, 36037, Germany

Location

Praxis Fr. Dr. J. Schmidt-Pich

Hanover, Lower Saxony, 30159, Germany

Location

Praxis Fr. Dr. A. Münzberger

Döbeln, Saxony, 04720, Germany

Location

Praxis Fr. Dr. K. Kopprasch

Dresden, Saxony, 01169, Germany

Location

Praxis Fr. R. Hellmich

Dresden, Saxony, 01187, Germany

Location

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Saxony, 04207, Germany

Location

Praxis Fr. Dr. C. Burgkhardt

Leipzig, Saxony, 04299, Germany

Location

Frauenarztpraxis Dr. Wetzel

Blankenburg, Saxony-Anhalt, 38889, Germany

Location

Frauenarztpraxis Dipl. med. Michael Stellmacher

Burg, Saxony-Anhalt, 39288, Germany

Location

Praxis Fr. Dr. A. Braune

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Praxis Hr. Prof. Dr. H.-J. Ahrendt

Magdeburg, Saxony-Anhalt, 39126, Germany

Location

Frauenarztpraxis Hr. Dr. H. Lindecke

Berlin, State of Berlin, 10247, Germany

Location

Praxis Fr. Dr. B. Heuberger

Berlin, State of Berlin, 12587, Germany

Location

Praxis Hr. Dr. Karl-Heinz Belling

Berlin, State of Berlin, 13086, Germany

Location

Frauenarztpraxis Hr. Dr. B. Hamann

Berlin, State of Berlin, 13187, Germany

Location

Praxis Hr. R. Wähnert

Gera, Thuringia, 07545, Germany

Location

Praxis Fr. Dr. A.Mönch-Hering

Kahla, Thuringia, 07768, Germany

Location

Related Publications (1)

  • Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.

    PMID: 19835717DERIVED

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Study Completion

September 1, 2006

Last Updated

July 15, 2011

Record last verified: 2011-07

Locations

CZ(5)FR(10)DE(19)