NCT00706784

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 13, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

4.5 years

First QC Date

June 25, 2008

Results QC Date

April 16, 2014

Last Update Submit

June 12, 2014

Conditions

Healthy

Keywords

Healthy women 18-40 years of age

Outcome Measures

Primary Outcomes (1)

  • Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion

    8 hours

Study Arms (1)

A

EXPERIMENTAL
Drug: Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System

Interventions

Ethylvinyl Acetate (EVA) Vaginal Ring Delivery SystemDRUG

Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System

A

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Unit for Research Trials In Skin (CURTIS)

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Extravehicular Activity

Intervention Hierarchy (Ancestors)

Space FlightAviationTransportationTechnology, Industry, and Agriculture

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Alexandra B. Kimball, MD
Organization
MGH
akimball@partners.org
617-726-5066

Study Officials

  • Alexandra B. Kimball, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 30, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

June 26, 2014

Results First Posted

June 13, 2014

Record last verified: 2014-06

Locations

US(1)