NCT02626208

Dose Finding Study of Contraceptive Vaginal Ring With Different Estradiol Levels in Combination With Nestorone

A Dose Finding Study to Evaluate Serum Estradiol Levels With Use of Contraceptive Vaginal Rings Releasing Nestorone® and Escalating Doses of Estradiol in Normal Cycling Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Premier Research · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Suppression of Ovulation

Interventions

Type	Name	Description
DEVICE	Nestorone®/Estradiol Contraceptive Vaginal Ring	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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-12-10
• Last updated: 2017-08-15

Locations

7 sites across 1 country: United States