To measure contraceptive efficacy of the test product
A randomized, single-blind, phase IIb/III controlled clinical trial to measure contraceptive efficacy of Mona Lisa NT Cu380 Mini.
Child to Adult
Women aged 16-40 with anticipated need for contraception of at least one year.
II/III - A combination of phases: (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. and (3) Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Comprehensive Women's Health Center
Comprehensive Womens Health Center
University of Colorado Hospital
Stephanie Teal, MD
Protocol Number: 17-0225
More information available at ClinicalTrials.gov: NCT03124160
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