Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

NCT07734155 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CH211 LR-303
• Study Type: interventional
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Contraceptive Usage

Keywords

contraception; female contraception; birth control; vaginal ring

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  Pregnancy test (urine and/or blood test)

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

Secondary Outcomes (3)

• Safety - adverse events

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

• safety - liver function

  Baseline, Month 6, Month 13

• safety - kidney function

  Baseline, Month 6, Month 13

Other Outcomes (8)

• Dual-energy X-ray absorptiometry (DXA) scan

  Baseline, Month 13

• Colposcopic evaluation of the vagina and cervix

  Baseline, Month 13

• Microbiologic test of the vagina

  Baseline, Month 13

Study Arms (1)

Levonorgestrel Vaginal Rind

EXPERIMENTAL

Levonorgestrel formulated in a vaginal ring for continuous 28 day use

Drug: Levonorgestrel

Interventions

Levonorgestrel DRUG

levonorgestrel formulated in a vaginal ring for continuous 28 day use

Also known as: CH211, LVS

Levonorgestrel Vaginal Rind

Eligibility Criteria

• Age: 13 Years - 45 Years
• Gender Eligibility Details: Female at birth
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chemo Research: lead

MeSH Terms

Conditions

Contraception Behavior

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Alicyoy Angulo, MD

CONTACT

34 91 771 15 00; alicyoy.angulo@external.chemogroup.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07