Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System Study - Full Text View

Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System Study (VaginalRing)

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, September 2009

First Received: June 25, 2008 Last Updated: September 18, 2009 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborator:	Combinent
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00706784

Purpose

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

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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To test the loading doses of E2, P, and GnRHa in the vaginal rings that will be required to completely ablate normal pituitary-ovarian function in women. [ Time Frame: One year ] [ Designated as safety issue: No ]

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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Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A history of normal regular menstrual cycles (25-35 days);
A normal physical examination;
A body mass index (BMI) between 19 & 29
A normal CBC, normal Prolactin level, normal LFT's
A negative urinary hCG at the initiation of each study; and
An agreement to refrain from attempting to conceive during the experimental cycle and the cycle thereafter by either abstinence and/or use of a barrier method of contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706784

Contacts

Contact: Lynne M Hermosilla

617-726-5066

harvardskinstudies@partners.org

Locations

United States, Massachusetts
Clinical Unit for Research Trials In Skin (CURTIS)	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Combinent

Investigators

Principal Investigator:

Alexandra B. Kimball, MD, MPH

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Alexandra B. Kimball, MD, MPH )
Study ID Numbers:	2004-P-001343
Study First Received:	June 25, 2008
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00706784 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Healthy women 18-50 years of age

ClinicalTrials.gov processed this record on February 08, 2010