Contraceptive Usage
Conditions
Keywords
contraception, female contraception, birth control, vaginal ring
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)
Interventions
DRUGLevonorgestrel
levonorgestrel formulated in a vaginal ring for continuous 28 day use
Sponsors
Chemo Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 45 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | Baseline, Month 1, Month 3, Month 6, Month 9, Month 13 | Pregnancy test (urine and/or blood test) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - adverse events | Baseline, Month 1, Month 3, Month 6, Month 9, Month 13 | Collection of adverse events |
| safety - liver function | Baseline, Month 6, Month 13 | 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). |
| safety - kidney function | Baseline, Month 6, Month 13 | 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. |
Contacts
CONTACTAlicyoy Angulo, MD
Outcome results
None listed