Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17β-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing

Autor: Sandra M. Cruz, Ingrid Duijkers, Christine Klipping, Tara L. Frenkl, Ghassan N. Fayad, Tjeerd Korver, Doris Heger-Mahn
Rok vydání: 2018
Předmět:
Adult
Nomegestrol acetate
medicine.medical_specialty
media_common.quotation_subject
Population
Ovulation Inhibition
Ethinyl Estradiol
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Internal medicine
Outcome Assessment
Health Care
Contraceptive Agents
Female
medicine
Humans
Endocrine system
Pharmacology (medical)
030212 general & internal medicine
education
Ovulation
Etonogestrel
Menstrual Cycle
Menstrual cycle
media_common
education.field_of_study
Desogestrel
Estrogens
Conjugated (USP)
030219 obstetrics & reproductive medicine
Dose-Response Relationship
Drug
Estradiol
business.industry
Contraceptive Devices
Female
Obstetrics and Gynecology
Vaginal ring
Drug Combinations
Endocrinology
Reproductive Medicine
chemistry
Female
Drug Monitoring
business
medicine.drug
Zdroj: The European Journal of Contraception & Reproductive Health Care. 23:245-254
ISSN: 1473-0782
1362-5187
Popis: To identify at least one contraceptive vaginal ring that effectively inhibits ovulation and demonstrates cycle control that is non-inferior to NuvaRingThis was a randomised, active controlled, parallel group, multicentre, partially blinded trial in healthy women 18-35 years of age. Subjects received one of six contraceptive vaginal rings with an average daily release rate of 300 µg 17β-estradiol (E2) and various rates of either etonogestrel (ENG; 75, 100, or 125 µg/day) or nomegestrol acetate (NOMAC; 500, 700, or 900 µg/day), or the active control NuvaRingOvulation inhibition was observed in all groups as confirmed by absence of progesterone concentrations compatible with ovulation (16 nmol/L) and absence of ultrasound evidence of ovulation. All investigational rings provided good cycle control, with the ENG-E2 125/300 µg/day group being associated with the best cycle control based on the numerically lowest incidence of unscheduled bleeding and absence of scheduled bleeding. Non-inferiority to NuvaRingContraceptive rings releasing 300 µg E2 and 75-125 µg/day of ENG or 500-900 µg/day of NOMAC provided adequate ovulation inhibition and cycle control and are generally well-tolerated. While non-inferiority to NuvaRing
Databáze: OpenAIRE
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