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Not yet recruiting NCT07734155

Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

Phase III Interventional Contraceptive Usage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levonorgestrel.
Who it may be relevant to
Registry conditions: Contraceptive Usage. Basic parameters: 13 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

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

Primary outcome measures

  • Pregnancy [Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 13]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07734155 · CH211 LR-303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗