Trial Condition(s):
Contraception
Efficacy and Safety Study of an oral contraceptive in healthy females
Bayer Identifier:
90959
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Healthy women between the ages of 18 and 35 years requiring contraception
Exclusion Criteria
- Pregnancy, lactation, and contraindication of combined oral contraceptive
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Comprehensive Clinical Trials West Palm Beach, United States, 33409 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research Palm Springs, United States, 33461 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lifespan Research Palo Alto, United States, 94301 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Health and Science University Portland, United States, 97239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seattle Women's: Health, Research, Gynecology Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women and Children's Hospital, Los Angeles Los Angeles, United States, 90033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Insignia Care for Women, P.A. Tampa, United States, 33607 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Trial Center of Colorado Castle Rock, United States, 80108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Médicale des Campus Ste-Foy, Canada, G1V 4X7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Recherche en Sante des Femmes Inc. Quebec, Canada, G1S 2L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diex Recherche Inc. Sherbrooke, Canada, J1H 1Z1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Temple Green Clinic Waterloo, Canada, N2L 6H6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Total Concept Health Care Inc. Kitchener, Canada, N2C 2N9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rhodin Recherche Clinique Drummondville, Canada, J2B 1H8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eastern Virginia Medical School Norfolk, United States, 23507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johns Hopkins Bayview Medical Center Baltimore, United States, 21224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Care Source Morristown, United States, 07960 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Age Medical Research Corp. Miami, United States, 33186 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Physicians Research Group Indianapolis, United States, 46250 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harbor - UCLA Medical Center Torrance, United States, 90509 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OB/GYN Health Center Medford, United States, 97504 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pittsburgh Medical Center Health System Pittsburgh, United States, 15213-2582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique de Gynecologie Shawinigan, Canada, G9N 2H6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Les Gynecologues Associes Montreal, Canada, H2X 1N8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'étude clinique de Montréal Inc. Montreal, Canada, H1T 1P6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of unintended pregnancies after 1 yearTimeframe: Throughout 1 year of treatment
Secondary Outcome
- Bleeding pattern and cycle control parameters after 1 yearTimeframe: Throughout 1 year of treatment
Additional Information
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