Status:
TERMINATED
Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System Study
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Combinent
Conditions:
Healthy
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
3-Day Study (outpatient) Healthy normal volunteers will participate in a 3-day outpatient study that will begin between days 1-7 of their menstrual cycle (i.e. early follicular phase). A negative uri...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00706784
Start Date
June 1 2008
End Date
June 1 2013
Last Update
June 26 2014
Active Locations (1)
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1
Clinical Unit for Research Trials In Skin (CURTIS)
Boston, Massachusetts, United States, 02115