Repeat use of the emergency contraceptive ulipristal acetate 30 mg is safe — Results from a multicenter pharmacodynamic study
ESC Congress Library. Jesam C. 05/28/14; 50535; A-120
Cristian Jesam
Cristian Jesam
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Abstract
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Objectives: Ulipristal acetate (UPA) 30 mg is both safe and effective for emergency contraception (EC). The objective of this study was to evaluate the safety and tolerability of repeated use of ulipristal acetate, as well as to assess the pharmacodynamic effect of multiple intakes on ovulation and other parameters of the menstrual cycle. This is the first report of repeat use of UPA 30 mg in the same cycle
Methods: Safety, tolerability and pharmacodynamics evaluation of repeat UPA 30 mg dosing was conducted in healthy volunteers at 2 sites. Treatment was administered either once a week (Q7D, n=12) or once every 5 days (Q5D, n=11) over 8 consecutive weeks. Subjects were administered UPA 30mg Q7D starting on day 7 (± 1) day of the cycle in the Dominican Republic site and Q5D starting on day 1 (+ 1) day of the cycle in the Chilean site. Laboratory safety parameters were assessed at baseline, at the end of treatment and at the end of study visit. Subjects were monitored 3 times a week with transvaginal ultrasounds and hormonal measurements during the period of treatment. Results: Repeated use of UPA 30 mg, taken weekly or every 5 days for 8 consecutive weeks, was as well tolerated as a single dose in terms of clinical safety profile, the most frequently reported adverse event was headache (13 %). Laboratory safety parameters remained without significant changes, including a full VTE risk markers panel. Inhibition of ovulation was not achieved with repeated dosing: 91.7% and 72.7% of the participants ovulated at least once during the 8 weeks of treatment, in the Q7D and Q5D treatment arms respectively. Ovulatory cycles had physiological levels of estradiol and progesterone. Conclusion: Although product labeling cautions that EC is not to be used as a regular contraceptive method, women may find themselves in need of EC more than once in a given cycle. This study demonstrates that repeat use of UPA 30 mg in the same cycle is safe and well tolerated. However, inhibition of ovulation is not consistently achieved with repeat use and its contraceptive protection is likely lower than that of a regular method.
Objectives: Ulipristal acetate (UPA) 30 mg is both safe and effective for emergency contraception (EC). The objective of this study was to evaluate the safety and tolerability of repeated use of ulipristal acetate, as well as to assess the pharmacodynamic effect of multiple intakes on ovulation and other parameters of the menstrual cycle. This is the first report of repeat use of UPA 30 mg in the same cycle
Methods: Safety, tolerability and pharmacodynamics evaluation of repeat UPA 30 mg dosing was conducted in healthy volunteers at 2 sites. Treatment was administered either once a week (Q7D, n=12) or once every 5 days (Q5D, n=11) over 8 consecutive weeks. Subjects were administered UPA 30mg Q7D starting on day 7 (± 1) day of the cycle in the Dominican Republic site and Q5D starting on day 1 (+ 1) day of the cycle in the Chilean site. Laboratory safety parameters were assessed at baseline, at the end of treatment and at the end of study visit. Subjects were monitored 3 times a week with transvaginal ultrasounds and hormonal measurements during the period of treatment. Results: Repeated use of UPA 30 mg, taken weekly or every 5 days for 8 consecutive weeks, was as well tolerated as a single dose in terms of clinical safety profile, the most frequently reported adverse event was headache (13 %). Laboratory safety parameters remained without significant changes, including a full VTE risk markers panel. Inhibition of ovulation was not achieved with repeated dosing: 91.7% and 72.7% of the participants ovulated at least once during the 8 weeks of treatment, in the Q7D and Q5D treatment arms respectively. Ovulatory cycles had physiological levels of estradiol and progesterone. Conclusion: Although product labeling cautions that EC is not to be used as a regular contraceptive method, women may find themselves in need of EC more than once in a given cycle. This study demonstrates that repeat use of UPA 30 mg in the same cycle is safe and well tolerated. However, inhibition of ovulation is not consistently achieved with repeat use and its contraceptive protection is likely lower than that of a regular method.
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