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Single-dose pharmacokinetics and pharmacodynamics assessment of oestriol and trimegestone containing vaginal rings in healthy women with childbearing potential.
- Source :
-
European Journal of Contraception & Reproductive Health Care . Jun2021, Vol. 26 Issue 3, p184-194. 11p. - Publication Year :
- 2021
-
Abstract
- <bold>Purpose: </bold>To evaluate the pharmacokinetics and pharmacodynamics of oestriol (E3) and trimegestone (TMG) in healthy women after application of three different vaginal rings over 21 days. The vaginal rings had a nominal delivery rate of 0.413/0.050 mg/day (Test 1), 0.311/0.090 mg/day (Test 2) and 0.209/0.137 mg/day (Test 3) E3/TMG.<bold>Methods: </bold>Thirty-five healthy women were randomised to receive a single application of Test 1, 2 or 3 (Clinical Trial NCT03343912). The E3 and TMG plasma concentration was determined by LC-MS/MS. Oestradiol (E2) and progesterone (PG) serum concentrations, and bleeding patern were determined as pharmacodynamic parameters. Safety was assessed by evaluation of adverse events and local tolerability.<bold>Results: </bold>The total and maximum exposure of E3 and TMG increased in a proportional ratio to dose. However, not in a magnitude which was expected from the dose differences for E3. During Test 2 and 3 treatment all E2 and PG values remained on a well suppressed level until end of treatment. E2 and PG serum levels increased distinctly earlier after ring removal with Test 1 compared to Test 2 and 3. Test 3 achieved 95.24% of "no bleeding" days under treatment followed by Test 1 (91.67%), and Test 2 (86.15%).<bold>Conclusions: </bold>The Test 3 formulation presented the best dose combination of E3/TMG for contraception. Moreover, all vaginal rings were well tolerated. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PHARMACOKINETICS
*PHARMACODYNAMICS
*HEMORRHAGE
*ESTRADIOL
*PROGESTERONE
*RESEARCH
*STEROIDS
*LIQUID chromatography
*RESEARCH methodology
*ESTROGEN
*MEDICAL cooperation
*EVALUATION research
*COMPARATIVE studies
*RANDOMIZED controlled trials
*MASS spectrometry
*VAGINAL medication
*CERVICAL caps
*STATISTICAL sampling
*ESTRIOL
*CONTRACEPTIVE drugs
Subjects
Details
- Language :
- English
- ISSN :
- 13625187
- Volume :
- 26
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- European Journal of Contraception & Reproductive Health Care
- Publication Type :
- Academic Journal
- Accession number :
- 150580272
- Full Text :
- https://doi.org/10.1080/13625187.2021.1884219