Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

NCT07734155 — Phase 3, Not yet recruiting, 1600 participants, Chemo Research

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Prospective, Multicenter, Open-label and Non-randomized Trial on Contraceptive Efficacy, Safety and Tolerability of LVS (Levonorgestrel Vaginal System) During 13 Cycles

Registry	NCT07734155
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	1600 (Estimated)
Sponsor	Chemo Research (Industry)
Conditions	Contraceptive Usage
Interventions	Levonorgestrel (Drug)
Dates	start 2026-12-01 (estimated), primary completion 2030-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-07-29, last updated 2026-07-29

-Summary

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)

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+Arms and interventions

Arm	Type	Interventions	Description
Levonorgestrel Vaginal Rind	Experimental	Drug: Levonorgestrel	Levonorgestrel formulated in a vaginal ring for continuous 28 day use

Levonorgestrel (Drug), also known as CH211, LVS: levonorgestrel formulated in a vaginal ring for continuous 28 day use

+Outcome measures

Primary outcomes

Pregnancy [Baseline, Month 1, Month 3, Month 6, Month 9, Month 13]: Pregnancy test (urine and/or blood test)

Secondary outcomes

Safety - adverse events [Baseline, Month 1, Month 3, Month 6, Month 9, Month 13]: Collection of adverse events
safety - liver function [Baseline, Month 6, Month 13]: 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).
safety - kidney function [Baseline, Month 6, Month 13]: 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.

Other outcomes

Dual-energy X-ray absorptiometry (DXA) scan [Baseline, Month 13]: To measure bone mineral density
Colposcopic evaluation of the vagina and cervix [Baseline, Month 13]: Evaluation of changes or adverse effects of the vagina and cervix
Microbiologic test of the vagina [Baseline, Month 13]: To evaluate change in vaginal flora and risk of vaginal infection
Endometrial histology [Baseline, Month 13]: Microscopic evaluation of the uterine lining
Pharmacokinetics - Cmax [Baseline, Month 6]: To evaluate maximun concentration
Population pharmacokinetics - Tmax [Baseline, Month 6]: To evaluate time to maximun concentration
Population pharmacokinetics - AUC [Baseline, Month 6]: To evaluate area under the curve to measure extent of exposure for dosing interval
Population pharmacokinetics - half life [Baseline, Month 6]: Measure the terminal half-life of levonorgestrel vaginal ring

+Eligibility

Sex: Female, ages: 13 Years to 45 Years

Inclusion:

* 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

Exclusion:

* Pregnant or desire of pregnancy
* Amenorrhea
* History of infertility or menopause or reproductive sterility
* Male sexual partner with infertility/sterility
* Known bleeding disorder or history of unknown bleeding/bruising
* Abnormal clinically significant findings on laboratory tests, physical, pelvic, breast, or ultrasound examination
* Papanicolaou (Pap) smear reading of low-grade squamous intraepithelial lesion (LSIL) or higher at screening
* History of: VTE, cardiovascular disease, major surgeries, diabetes mellitus, severe hepatic disease, renal insufficiency, adrenal insufficiency, sex steroid sensitive malignancy, breast cancer, HPV infections
* Uncontrolled chronic disease
* Severe DOCID-19
* Progestin releasing IUD use, implant contraception use
* Planned regular use of barrier contraceptive methods, spermicide, IUDs, other contraceptive measures