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Sponsors and Collaborators: |
Massachusetts General Hospital Combinent |
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00706784 |
This research study is looking at how well a new drug delivery system, called the vaginal ring, works to get hormones into your body as a form of birth control.
Condition | Intervention | Phase |
Healthy |
Drug: Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System |
Phase I Phase II |
Drug Information available for: | Gonadorelin Gonadorelin hydrochloride LH-RH |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Inducing a Medical Castration With a GnRH Agonist While Simultaneously Replacing Physiologic Levels and Patterns of Human Sex Steroid Hormones Using an Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System |
Estimated Enrollment: | 120 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental |
Drug: Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System
Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contact: Lynne M Hermosilla | 617-726-5066 | harvardskinstudies@partners.org |
United States, Massachusetts | |||||
Clinical Unit for Research Trials In Skin (CURTIS) | Recruiting | ||||
Boston, Massachusetts, United States, 02115 |
Massachusetts General Hospital |
Combinent |
Principal Investigator: | Alexandra B. Kimball, MD, MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Alexandra B. Kimball, MD, MPH ) |
Study ID Numbers: | 2004-P-001343 |
First Received: | June 25, 2008 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00706784 |
Health Authority: | United States: Food and Drug Administration |
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