Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age13-45
SponsorChemo Research

About this trial

The goal of this clinical trial is to learn if drug levonorgestrel vaginal ring works as a contraceptive adult and adolescent females who are able to conceive (i.e. get pregnant). It will also learn about the safety and tolerability of levonorgestrel vaginal ring. The main questions it aims to answer are:

Does drug levonorgestrel vaginal ring lower the number of pregnancies with continued use? What adverse effects do participants experience by using levonorestrel vaginal ring? Researchers will count the number of pregnancies with levonorgestrel vaginal ring after a participant uses it for a year to see if the number of pregnancies is low (i.e. women and girls do not get pregnant).

Participants will:

Use levonorgestrel vaginal ring for 28 days (called one cycle); for a total of 14 cycles (which is a little more than year) Visit the clinic about 8 to 10 times over about 14 months for checkups and tests with an additional approximately 13 phone calls Keep a diary of their pregnancies and number of times they use additional contraceptive (e.g. condoms)

Eligibility criteria

Qualifiers

Female between age 13 and 45 years

Sexually active and of child-bearing potential

Not pregnant with regular menstrual cycles

Blood pressure: ≤ 140 mmHg systolic and ≤ 90 mmHg diastolic

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Levonorgestrel

Treatment groups

1,600 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators