Pharmacological data of two vaginal contraceptive rings Pregnancy and Childbirth
Conditions
Interventions
Vaginal contraceptive ring containing: two female sex hormones – ethinylestradiol and etonogestrel. The ring slowly releases these hormones into the blood circulation. The ring releases ethinylestradi
Sponsors
Laboratorios Liconsa
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Signature and dating of this consent form 2. Review of medical and medication history 3. Recording of demographical data (age, sex, race, body weight, height, and BMI) and alcohol and smoking habits 4. Full physical exam 5. Vital signs measurement (blood pressure, heart rate and body temperature) 6. Electrocardiogram (ECG) - a recording of the electrical activity of your heart 7. Blood and urine samples for laboratory tests 8. Blood pregnancy test 9. Alcohol breath test 10. Urine drug screen to test for drugs of abuse (amphetamines, barbiturates, cannabinoids, cocaine, cotinine, opiates and phencyclidine) 11. Urine cotinine test to find out if you have smoked nicotine products 12. Breast and Gynecological exam 13. Pap smear to detect vaginal or uterine cancer (if not performed at Altasciences in the past 12 months) 14. Blood test for HIV and hepatitis B and C. Note that a positive test result must be reported to the public health authorities, as required by law
Exclusion criteria
Exclusion criteria: 1. BMI >=30 kg/m2 2. No clinically significant pathological physical examination or laboratory results (haematology, general biochemistry, ECG, urinalysis, and PAP smear) or medical history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum etonogestrel/ethinylestradiol (3-Ketodesogestrel and ethylestradiol) levels were measured using high-performance liquid chromatography technology with tandem mass spectrometry detection. Blood samples were taken before and at 1.00, 3.00, 6.00, 9.00, and 12.00 hours to perform PK measures. The next hours were 24, 48, 72, 96, 120, 168, 216, 264, 312, 336, 360, 432, 504, 528, 576, and 624, 672, 675, 678, 684, 688, 696, 720, 744, and 792 hours after vaginal ring insertion (for Etonogestrel alone). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability measured using data collected from electronic Case Report Forms (eCRF) at the end of the study 2. User-friendliness measured using an electronic diary at the end of period 1 (after 28 days ) and period 2 (after 28 days) | — |
Countries
Canada
Contacts
Public ContactPedro Antonio Regidor
Outcome results
None listed