Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

ConditionContraceptive Usage

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Levonorgestrel
Drug
levonorgestrel formulated in a vaginal ring for continuous 28 day use

Treatment groups

1,600 Participants

are divided into 1 treatment group

Group A: Levonorgestrel Vaginal RindExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pregnancy

Pregnancy test (urine and/or blood test)

Time frame

Baseline, Month 1, Month 3, Month 6, Month 9, Month 13

Secondary outcomes

Safety - adverse events

Collection of adverse events

Time frame

Baseline, Month 1, Month 3, Month 6, Month 9, Month 13

safety - liver function

Blood test of liver panel to include: albumin, total cholesterol (HDL, LDL cholesterol), triglycerides, gamma glutamyl transferase, total and direct bilirubin, alkaline phosphatase (ALP), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), creatine phosphokinase (CPK), lactate dehydrogenase (LDH).

Time frame

Baseline, Month 6, Month 13

safety - kidney function

Urinalysis (local dipstick): leukocytes, nitrite, protein, glucose, ketones, blood, pH, urobilinogen, bilirubin. If any of the measured parameters of urine analysis is out of range/pathologic, the sample will be shipped to the laboratory for microscopic examination.

Time frame

Baseline, Month 6, Month 13

Other outcomes

Dual-energy X-ray absorptiometry (DXA) scan

To measure bone mineral density

Time frame

Baseline, Month 13

Colposcopic evaluation of the vagina and cervix

Evaluation of changes or adverse effects of the vagina and cervix

Time frame

Baseline, Month 13

Microbiologic test of the vagina

To evaluate change in vaginal flora and risk of vaginal infection

Time frame

Baseline, Month 13

Endometrial histology

Microscopic evaluation of the uterine lining

Time frame

Baseline, Month 13

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chemo Research

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: