Contraceptive UsagePhase 3NCT07734155
Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System
A Phase 3 study testing Levonorgestrel in people with Contraceptive Usage, run by Chemo Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 45 years, women only
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Levonorgestrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multicenter, Open-label and Non-randomized Trial on Contraceptive Efficacy, Safety and Tolerability of LVS (Levonorgestrel Vaginal System) During 13 Cycles
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).
Read more
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)
- Conditions
- Contraceptive Usage
- Being tested
- Levonorgestrel
- Keywords
- contraception, female contraception, birth control, vaginal ring
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevonorgestrelDrug
Also called CH211, LVS
levonorgestrel formulated in a vaginal ring for continuous 28 day use
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel Vaginal Rind | Experimental | Levonorgestrel formulated in a vaginal ring for continuous 28 day use Receives: Drug: Levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Pregnancy test (urine and/or blood test)
Measured: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13
Secondary outcomes (3)
Safety - adverse events
Collection of adverse events
Measured: 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).
Measured: 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.
Measured: Baseline, Month 6, Month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chemo Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734155
- Sponsor's protocol ID
- CH211 LR-303
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This topic is still in discussion and review internally. Once a decision is completed, the IPD plan will be updated.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open-label and Non-randomized Trial on Contraceptive Efficacy, Safety and Tolerability of LVS (Levonorgestrel Vaginal System) During 13 Cycles
- ClinicalTrials.gov ID
- NCT07734155
- Acronym / sponsor ID
- CH211 LR-303
- Conditions
- Contraceptive Usage
- Keywords
- contraception, female contraception, birth control, vaginal ring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Chemo ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel Vaginal Rind | Experimental | Drug: LevonorgestrelLevonorgestrel formulated in a vaginal ring for continuous 28 day use |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevonorgestrelAlso: CH211, LVSlevonorgestrel formulated in a vaginal ring for continuous 28 day use | Drug | Levonorgestrel Vaginal Rind |
Primary outcome
Pregnancy
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13
Pregnancy test (urine and/or blood test)
3 secondary outcomes
Safety - adverse events
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13
safety - liver function
Time frame: Baseline, Month 6, Month 13
safety - kidney function
Time frame: Baseline, Month 6, Month 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided. This topic is still in discussion and review internally. Once a decision is completed, the IPD plan will be updated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levonorgestrel in people with Contraceptive Usage, run by Chemo Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicyoy Angulo, MD (34 91 771 15 00, alicyoy.angulo@external.chemogroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.