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A multi-center, single-blind, randomized clinical trial to compare two copper IUDs:Mona Lisa NT Cu380 Mini and ParaGard

Primary Objective

To measure contraceptive efficacy of the test product

Study category: Healthy Volunteers

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Description

A randomized, single-blind, phase IIb/III controlled clinical trial to measure contraceptive efficacy of Mona Lisa NT Cu380 Mini.

Details
Age

Child to Adult

Eligibility

Women aged 16-40 with anticipated need for contraception of at least one year.

Phase

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.

Type of Study

Outcomes Research

Scope

National

Locations

Comprehensive Women's Health Center
Comprehensive Womens Health Center
University of Colorado Hospital

Principal Investigator
Stephanie Teal,  MD

Stephanie Teal, MD

Study ID

Protocol Number: 17-0225

ClinicalTrials.gov: NCT03124160

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