Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Detailed Description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

• Study Type: Interventional
• Enrollment (Actual): 499
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy women between the ages of 18 and 35 years requiring contraception

Exclusion Criteria:

• Pregnancy, lactation, and contraindication of combined oral contraceptive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EV/DNG (Qlaira, BAY86-5027); Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID); GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of unintended pregnancies after 1 year	Throughout 1 year of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Bleeding pattern and cycle control parameters after 1 year	Throughout 1 year of treatment

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 30, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 90959; 304742 (Other Identifier: Company internal)