ClinicalTrials.gg
Not yet recruitingNCT07734155Updated Jul 29, 2026

Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

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

Phase
Phase 3
Study type
Interventional
Enrollment
1,600
Allocation
Not applicable
Ages
13 Years to 45 Years
Sex
Female
01

Study 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)

02

Conditions studied

  • Contraceptive Usage

Keywords

  • contraception
  • female contraception
  • birth control
  • vaginal ring
03

In context

Contraception Behavior

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
13 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Female between age 13 and 45 years
  • Sexually active and of
  • Not pregnant with regular menstrual cycles
  • Blood pressure: ≤ 140 mmHg systolic and ≤ 90 mmHg diastolic

Exclusion criteria

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 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 sensitive , breast cancer, HPV infections
  • Uncontrolled chronic disease
  • Severe DOCID-19
  • Progestin releasing IUD use, implant use
  • Planned regular use of barrier contraceptive methods, spermicide, IUDs, other contraceptive measures
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,600 participants (estimated)

Study arms

  • Experimental
    Levonorgestrel Vaginal Rind

    Levonorgestrel formulated in a vaginal ring for continuous 28 day use

    Drug: Levonorgestrel

Interventions

  • levonorgestrel formulated in a vaginal ring for continuous 28 day use

    Also known as: CH211, LVS

06

What researchers measure

Primary outcomes

  1. Pregnancy

    Pregnancy test (urine and/or blood test)

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13

Secondary outcomes

  1. Safety - adverse events

    Collection of adverse events

    Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13

  2. 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

  3. 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

  1. Dual-energy X-ray absorptiometry (DXA) scan

    To measure bone mineral density

    Time frame: Baseline, Month 13

  2. Colposcopic evaluation of the vagina and cervix

    Evaluation of changes or adverse effects of the vagina and cervix

    Time frame: Baseline, Month 13

  3. Microbiologic test of the vagina

    To evaluate change in vaginal flora and risk of vaginal infection

    Time frame: Baseline, Month 13

  4. Endometrial histology

    Microscopic evaluation of the uterine lining

    Time frame: Baseline, Month 13

  5. Pharmacokinetics - Cmax

    To evaluate maximun concentration

    Time frame: Baseline, Month 6

  6. Population pharmacokinetics - Tmax

    To evaluate time to maximun concentration

    Time frame: Baseline, Month 6

  7. Population pharmacokinetics - AUC

    To evaluate area under the curve to measure extent of exposure for dosing interval

    Time frame: Baseline, Month 6

  8. Population pharmacokinetics - half life

    Measure the terminal half-life of levonorgestrel vaginal ring

    Time frame: Baseline, Month 6

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Jul 20, 2026
First posted
Jul 29, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Jul 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07734155
Lead sponsor
Chemo Research
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jul 29, 2026

Study contacts

Alicyoy Angulo, MD
Contact
alicyoy.angulo@external.chemogroup.com
34 91 771 15 00

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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Studies of the drug tested here: Levonorgestrel

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