Skip to main content
Clinical Trials/NCT00706784
NCT00706784TerminatedPhase 1

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

Massachusetts General Hospital1 site in 1 country6 target enrollmentStarted: June 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
6
Locations
1
Primary Endpoint
Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion

Study Overview

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 urinary hCG will be obtained in these women prior to their starting the 3-day study. On the first day, subjects will have 4 baseline blood samples of 5mL each drawn at 20-minute intervals over an hour (Time = 0, +20, +40, +60). These will be pooled and will represent the pretreatment determination of gonadotropins and sex steroid levels. Thereafter, the individual vaginal rings to be tested will be inserted. Over the ensuing 3 days, subjects will have 3 blood draws per day (at approximately 8-9 AM, 12-1PM, and 4-5PM).

Serum levels of LH, FSH, E2, and P will be determined at the above time points for the next 3 days. A repeat CBC and LFT's will be done with the final blood draw. The only exceptions to this protocol will be those patients with the Sex Steroid Only rings in whom 75 ug/kg of a GnRH antagonist (Acyline IND# 58,448) will be administered subcutaneously every other day and upon subsequent onset of menses, subjects will return during day 3-6 for repeat LFT's and gonadotropins. This will ensure the return of normal liver function and hormonal levels.

A visual vaginal examination and colposcopy will be done at baseline and at the time of the removal of the ring. If lesions or abrasions are found at study termination, subjects will be followed until the lesions resolve. For the initial 3-day studies, daily visual inspection of the vaginal tissues will be conducted and findings recorded in a standardized manner.

The schedule of more intensive early sampling is selected to be certain that no rapid release of medication occurs from the rings during the earliest phase following their insertion. This will also document that we have, in fact, achieved a steady state of release of the ring's content in the circulation prior to expanding the duration of these studies to 14 days in the second portion of part A.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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 Criteria

  • Not provided

Arms & Interventions

A

Experimental

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

Outcomes

Primary Outcomes

Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion

Time Frame: 8 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexandra Kimball

Principal Investigator

Massachusetts General Hospital

Study Sites (1)

Loading locations...

Similar Trials

Ethylvinyl Acetate (EVA) Vaginal Ring... | Clinical Trial