Study of Safety and Efficacy of an Oral Contraceptive
Recruiting in Palo Alto (17 mi)
+54 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Warner Chilcott
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
Research Team
HE
Herman Ellman, MD
Principal Investigator
Sponsor GmbH
Eligibility Criteria
Inclusion Criteria
Healthy Women
Age 18-45
At risk for pregnancy
See 1 more
Treatment Details
Interventions
- Norethindrone acetate/ethinyl estradiol (Combination Hormone Contraceptive)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: study drugExperimental Treatment1 Intervention
Norethindrone/Ethinyl Estradiol
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Warner Chilcott Investigational SitePhoenix, AZ
Warner Chilcott Investigational SitePeoria, IL
Warner Chilcott Investigational SiteColumbia, SC
Warner Chilcott Investigational SiteBoynton Beach, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Warner Chilcott
Lead Sponsor
Trials
61
Patients Recruited
25,200+