Contraception Clinical Trial
Official title:
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
| Verified date | September 2014 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug AdministrationCanada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 499 |
| Est. completion date | July 2007 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 35 Years |
| Eligibility |
Inclusion Criteria: - Healthy women between the ages of 18 and 35 years requiring contraception Exclusion Criteria: - Pregnancy, lactation, and contraindication of combined oral contraceptive |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Rhodin Recherche Clinique | Drummondville | Quebec |
| Canada | Total Concept Health Care Inc. | Kitchener | Ontario |
| Canada | Centre d'étude clinique de Montréal Inc. | Montreal | Quebec |
| Canada | Les Gynecologues Associes | Montreal | Quebec |
| Canada | Clinique Recherche en Sante des Femmes Inc. | Quebec | |
| Canada | Clinique de Gynecologie | Shawinigan | Quebec |
| Canada | Diex Recherche Inc. | Sherbrooke | Quebec |
| Canada | Clinique Médicale des Campus | Ste-Foy | Quebec |
| Canada | Temple Green Clinic | Waterloo | Ontario |
| United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
| United States | Clinical Trial Center of Colorado | Castle Rock | Colorado |
| United States | Physicians Research Group | Indianapolis | Indiana |
| United States | Women's Clinic of Lincoln, PC | Lincoln | Nebraska |
| United States | Women and Children's Hospital, Los Angeles | Los Angeles | California |
| United States | OB/GYN Health Center | Medford | Oregon |
| United States | New Age Medical Research Corp. | Miami | Florida |
| United States | Women's Care Source | Morristown | New Jersey |
| United States | Eastern Virginia Medical School | Norfolk | Virginia |
| United States | Visions Clinical Research | Palm Springs | Florida |
| United States | Lifespan Research | Palo Alto | California |
| United States | Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Genesis Center for Clinical Research | San Diego | California |
| United States | Medical Center for Clinical Research | San Diego | California |
| United States | Seattle Women's: Health, Research, Gynecology | Seattle | Washington |
| United States | Insignia Care for Women, P.A. | Tampa | Florida |
| United States | Harbor - UCLA Medical Center | Torrance | California |
| United States | Comprehensive Clinical Trials | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of unintended pregnancies after 1 year | Throughout 1 year of treatment | No | |
| Secondary | Bleeding pattern and cycle control parameters after 1 year | Throughout 1 year of treatment | No |
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