check_circleStudy Completed

Contraception

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
  • - Healthy women between the ages of 18 and 35 years requiring contraception
  • - Pregnancy, lactation, and contraindication of combined oral contraceptive

Trial summary

Enrollment Goal
499
Trial Dates
March 2005 - July 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Comprehensive Clinical TrialsWest Palm Beach, 33409, United States
Completed
Visions Clinical ResearchPalm Springs, 33461, United States
Completed
Lifespan ResearchPalo Alto, 94301, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
Seattle Women's: Health, Research, GynecologySeattle, 98105, United States
Completed
Women's Clinic of Lincoln, PCLincoln, 68510, United States
Completed
Women and Children's Hospital, Los AngelesLos Angeles, 90033, United States
Completed
Insignia Care for Women, P.A.Tampa, 33607, United States
Completed
Clinical Trial Center of ColoradoCastle Rock, 80108, United States
Completed
Clinique Médicale des CampusSte-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 ClinicWaterloo, N2L 6H6, Canada
Completed
Total Concept Health Care Inc.Kitchener, N2C 2N9, Canada
Completed
Rhodin Recherche CliniqueDrummondville, J2B 1H8, Canada
Completed
Eastern Virginia Medical SchoolNorfolk, 23507, United States
Completed
Johns Hopkins Bayview Medical CenterBaltimore, 21224, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
Women's Care SourceMorristown, 07960, United States
Completed
New Age Medical Research Corp.Miami, 33186, United States
Completed
Physicians Research GroupIndianapolis, 46250, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Harbor - UCLA Medical CenterTorrance, 90509, United States
Completed
OB/GYN Health CenterMedford, 97504, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15213-2582, United States
Completed
Clinique de GynecologieShawinigan, G9N 2H6, Canada
Completed
Les Gynecologues AssociesMontreal, H2X 1N8, Canada
Completed
Centre d'étude clinique de Montréal Inc.Montreal, H1T 1P6, Canada

Primary Outcome

  • Number of unintended pregnancies after 1 year
    date_rangeTime Frame:
    Throughout 1 year of treatment
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Bleeding pattern and cycle control parameters after 1 year
    date_rangeTime Frame:
    Throughout 1 year of treatment
    enhanced_encryption
    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
1