This clinical trial investigates a new vaginal delivery system made of silicone rubber, containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings that contain a fixed dose of NES and escalating doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR for a larger contraceptive efficacy trial.
This dose-finding study aims to evaluate serum estradiol levels with use of contraceptive vaginal rings releasing Nestorone® and escalating doses of estradiol in normal cycling women. The primary objective is to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings containing a fixed dose of Nestorone® (NES) and escalating doses of estradiol as the basis for selecting a contraceptive vaginal ring (CVR) dose for a contraceptive efficacy trial. The secondary objectives are to evaluate the effects of three different estradiol doses of a NES- E2 CVR on progesterone levels, bleeding and side effects during one month of use and to evaluate the effects of a hormone-free internal on bleeding patterns. Nestorone serum levels will further be measured as an indication of compliance with the continuous use of the ring.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
65
Three arms of contraceptive vaginal rings contain a fixed dose (200 mcg/day) of Nestorone® and escalating doses (75 µg/d, 100 µg/d, or 200 µg/d /day) of estradiol
University of California, Davis
Sacramento, California, United States
Columbia University
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health & Science Unit
Portland, Oregon, United States
Change in serum estradiol (E2) levels of three different contraceptive vaginal rings
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Change in progesterone levels
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Vaginal bleeding- amount and frequency
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
Adverse event
Time frame: Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Eastern Virginia Medical School (EVMS)
Norfolk, Virginia, United States