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Sponsors and Collaborators: |
ReProtect Inc Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Health Decisions |
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Information provided by: | ReProtect Inc |
ClinicalTrials.gov Identifier: | NCT00397670 |
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.
Condition | Intervention | Phase |
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Contraception |
Drug: Drug: BufferGel® with diaphragm |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Open-Label Study of the Safety and Contraceptive Efficacy of BufferGel® Spermicide Used With Diaphragm |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
In addition, in order to be eligible to participate in the trial, potential subjects must state that, to her best knowledge, her sexual partner meets the following criteria:
Study ID Numbers: | CCN 003OL |
Study First Received: | November 8, 2006 |
Last Updated: | November 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00397670 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Contraceptive Agents |
Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Reproductive Control Agents Pharmacologic Actions |