Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System

Phase 3Not Yet RecruitingNCT07734155

Chemo Research1,600 enrolled

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

1,600

Conditions

Contraceptive Usage

Interventions

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pregnancy

Pregnancy test (urine and/or blood test)

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

Secondary Outcomes

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.