Study Completed

Contraception

Bayer Identifier:

90959

ClinicalTrials.gov Identifier:

NCT00206583

EudraCT Number:

Not Available

EU CT Number:

Not Available

Efficacy and Safety Study of an oral contraceptive in healthy females

Trial purpose

The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

Trial summary

Enrollment Goal

499

Trial Dates

March 2005 - July 2007

Phase

Phase 3

Could I Receive a placebo

Products

Natazia/Qlaira (EV/DNG, BAY86-5027)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Comprehensive Clinical Trials	West Palm Beach, 33409, United States
Completed	Visions Clinical Research	Palm Springs, 33461, United States
Completed	Lifespan Research	Palo Alto, 94301, United States
Completed	Oregon Health and Science University	Portland, 97239, United States
Completed	Seattle Women's: Health, Research, Gynecology	Seattle, 98105, United States
Completed	Women's Clinic of Lincoln, PC	Lincoln, 68510, United States
Completed	Women and Children's Hospital, Los Angeles	Los Angeles, 90033, United States
Completed	Insignia Care for Women, P.A.	Tampa, 33607, United States
Completed	Clinical Trial Center of Colorado	Castle Rock, 80108, United States
Completed	Clinique Médicale des Campus	Ste-Foy, G1V 4X7, Canada
Completed	Clinique Recherche en Sante des Femmes Inc.	Quebec, G1S 2L6, Canada
Completed	Diex Recherche Inc.	Sherbrooke, J1H 1Z1, Canada
Completed	Temple Green Clinic	Waterloo, N2L 6H6, Canada
Completed	Total Concept Health Care Inc.	Kitchener, N2C 2N9, Canada
Completed	Rhodin Recherche Clinique	Drummondville, J2B 1H8, Canada
Completed	Eastern Virginia Medical School	Norfolk, 23507, United States
Completed	Johns Hopkins Bayview Medical Center	Baltimore, 21224, United States
Completed	Genesis Center for Clinical Research	San Diego, 92103, United States
Completed	Women's Care Source	Morristown, 07960, United States
Completed	New Age Medical Research Corp.	Miami, 33186, United States
Completed	Physicians Research Group	Indianapolis, 46250, United States
Completed	Medical Center for Clinical Research	San Diego, 92108, United States
Completed	Harbor - UCLA Medical Center	Torrance, 90509, United States
Completed	OB/GYN Health Center	Medford, 97504, United States
Completed	Clinical Research of Philadelphia, LLC	Philadelphia, 19114, United States
Completed	University of Pittsburgh Medical Center Health System	Pittsburgh, 15213-2582, United States
Completed	Clinique de Gynecologie	Shawinigan, G9N 2H6, Canada
Completed	Les Gynecologues Associes	Montreal, H2X 1N8, Canada
Completed	Centre d'étude clinique de Montréal Inc.	Montreal, H1T 1P6, Canada

Primary Outcome

Number of unintended pregnancies after 1 year
Time Frame:
Throughout 1 year of treatment
Safety Issue:
no

Secondary Outcome

Bleeding pattern and cycle control parameters after 1 year
Time Frame:
Throughout 1 year of treatment
Safety Issue:
no

Trial design

A multicenter, open-label uncontrolled study to investigate the efficacy and safety of a 4-phasic oral contraceptive SH T0065 in a 28-day regimen for 13 cycles in healthy female subjects

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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