Bioequivalence Evaluation of a Folate-Supplemented Oral Contraceptive Containing Ethinylestradiol/Drospirenone/Levomefolate Calcium versus Ethinylestradiol/Drospirenone and Levomefolate Calcium Alone

Abstract

The novel folate-supplemented OC EE/drospirenone/levomefolate calcium is bioequivalent to the established OC Yasmin® (EE/drospirenone components) and to levomefolate calcium (folate component).

The Effectiveness of Folate-Fortified Oral Contraceptives in Maintaining Optimal Folate Levels to Protect Against Neural Tube Defects: A Systematic Review

“…Ultimately, five articles met the final inclusion criteria. [8][9][10][11][12] The five studies presented in this category are summarized in the Table. Bioequivalence studies Wiesinger et al 9 conducted a randomized, open-label, threeperiod, crossover study at a single centre in Germany to evaluate the bioequivalence of a new folate-supplemented oral contraceptive preparation (containing ethinyl estradiol, drospirenone, and levomefolate calcium) with its nonsupplemented counterpart (containing ethinyl estradiol and drospirenone) and levomefolate calcium (5-methyl-THF) separately. Within this intra-individual crossover design, each participant was randomized to a treatment sequence that included: Each treatment commenced between the third and sixth days of the participant's menstrual cycle, and each treatment was administered as a single dose orally, along with extensive dietary restrictions that were standardized across all participants.…”

Sex differences in the pharmacokinetics and bioequivalence of the delayed-release combination of doxylamine succinate-pyridoxine hydrochloride; implications for pharmacotherapy in pregnancy

“…Furthermore, for BE studies, enrolment of participants from a single sex may be justified, but is not a requirement . For example, bioequivalence studies conducted for oral contraceptives are generally only conducted in females of childbearing age …”

“…13 For example, bioequivalence studies conducted for oral contraceptives are generally only conducted in females of childbearing age. [14][15][16][17][18] Currently, the only medication labeled for the management of nausea and vomiting of pregnancy (NVP), the most common medical condition in pregnancy, affecting 80% of females 19 is a delayed-release prescription medication composed of 10 mg doxylamine succinate, an anti-histamine, and 10 mg pyridoxine hydrochloride, also known as vitamin B6 (Diclectin ® ; Diclegis ® ). 20 The combination of these two unrelated active ingredients has shown a synergistic effect in the treatment of NVP.…”