A Phase 3 interventional study of Levonorgestrel in Contraceptive Usage, sponsored by Chemo Research. Not yet recruiting. Open to female participants aged 13 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Chemo Research · Phase 3, Interventional, and Prevention
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)
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →Chemo Research is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Levonorgestrel formulated in a vaginal ring for continuous 28 day use
Drug: Levonorgestrel
levonorgestrel formulated in a vaginal ring for continuous 28 day use
Also known as: CH211, LVS
Pregnancy
Pregnancy test (urine and/or blood test)
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13
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
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
Pharmacokinetics - Cmax
To evaluate maximun concentration
Time frame: Baseline, Month 6
Population pharmacokinetics - Tmax
To evaluate time to maximun concentration
Time frame: Baseline, Month 6
Population pharmacokinetics - AUC
To evaluate area under the curve to measure extent of exposure for dosing interval
Time frame: Baseline, Month 6
Population pharmacokinetics - half life
Measure the terminal half-life of levonorgestrel vaginal ring
Time frame: Baseline, Month 6
No study locations are listed for this record.
Plan to share: Undecided — This topic is still in discussion and review internally. Once a decision is completed, the IPD plan will be updated.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2030, 48 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levonorgestrel
Chemo Research