A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg

Abstract

STUDY QUESTIONWill the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method?SUMMARY ANSWERTypical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population.WHAT IS KNOWN ALREADYLNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception.STUDY DESIGN, SIZE, DURATIONThis was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014.PARTICIPANTS/MATERIALS, SETTING, METHODSA total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability questions were administered.MAIN RESULTS AND THE ROLE OF CHANCEThere were 321 women included in the evaluable population (which includes all eligible women enrolled), with 141.9 woman-years (W-Y) of observation and with a rate (95% confidence interval [CI]) of 7.1 (3.8; 13.1) pregnancies per 100 W-Y of typical use (which reflects use of the study drug as main contraceptive method, but also includes possible use of other contraceptives from admission to end of study) and 7.5 (4.0; 13.9) pregnancies per 100 W-Y of sole use. In the primary evaluable population (which includes only eligible enrolled women <35 years old), the rate was 10.3 (5.4; 19.9) pregnancies per 100 W-Y of typical use, and 11.0 (5.7; 13.1) pregnancies per 100 W-Y of sole use. There were three reported severe adverse events and 102 other mild adverse events (most common were headache, nausea, abdominal and pelvic pain), with high recovery rate. The vaginal bleeding patterns showed a slight decrease in volume of bleeding and the number of bleeding-free days increased over time. There was only one case o...

Feasibility of e-commerce pharmacy provision and acceptability of levonorgestrel 1.5 mg for pericoital use in urban and peri-urban settings in Kenya: a prospective cohort study

“…Moreover, more than a third (37%) of adopters obtained the study pill more than once, suggesting potential demand and acceptability of a pericoital FP method. Our findings are consistent with a previous study that showed high acceptability of LNG 1.5 mg for pericoital use in multiple countries: Hungary, Thailand, Singapore and Brazil 10. Furthermore, the study pill appeals to women having infrequent sex.…”

Feasibility of e-commerce pharmacy provision and acceptability of levonorgestrel 1.5 mg for pericoital use in urban and peri-urban settings in Kenya: a prospective cohort study

“…Moreover, more than a third (37%) of adopters obtained the study pill more than once, suggesting potential demand and acceptability of a pericoital FP method. Our findings are consistent with a previous study that showed high acceptability of LNG 1.5 mg for pericoital use in multiple countries: Hungary, Thailand, Singapore and Brazil 10. Furthermore, the study pill appeals to women having infrequent sex.…”

Feasibility and Acceptability of LNG 1.5 mg as an On‐Demand Pericoital Contraceptive in Ghana

“…This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al. 2016; Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al.…”

“…Furthermore, women used the method as instructed, as their main form of contraception, and while the results were self-reported, repeat use appeared safe. This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al 2016;Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al (2016) and was observed throughout this study.…”

“…This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al 2016;Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al (2016) and was observed throughout this study. Bleeding had the highest average intensity of side effects reported, and the most frequently cited response for not liking the method was changes in their menstrual cycle.…”

“…Within the study, women who have infrequent sex demonstrated a high degree of satisfaction and intent to use the method in the future. This aligns well with previous studies, which demonstrated demand and acceptability with a theoretical method (e.g., Chin-Quee, L'Engle, and Otterness 2014; Cover et al 2013a) and within actual study conditions (i.e., Festin et al 2016). Furthermore, women used the method as instructed, as their main form of contraception, and while the results were self-reported, repeat use appeared safe.…”

Feasibility of e-commerce pharmacy provision and acceptability of levonorgestrel 1.5 mg for pericoital use in urban and peri-urban settings in Kenya: a prospective cohort study

“…Moreover, more than a third (37%) of adopters obtained the study pill more than once, suggesting potential demand and acceptability of a pericoital FP method. Our findings are consistent with a previous study that showed high acceptability of LNG 1.5 mg for pericoital use in multiple countries: Hungary, Thailand, Singapore and Brazil 10. Furthermore, the study pill appeals to women having infrequent sex.…”

Feasibility and Acceptability of LNG 1.5 mg as an On‐Demand Pericoital Contraceptive in Ghana

“…This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al. 2016; Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al.…”

“…Furthermore, women used the method as instructed, as their main form of contraception, and while the results were self-reported, repeat use appeared safe. This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al 2016;Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al (2016) and was observed throughout this study.…”

“…This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al 2016;Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al (2016) and was observed throughout this study. Bleeding had the highest average intensity of side effects reported, and the most frequently cited response for not liking the method was changes in their menstrual cycle.…”

“…Within the study, women who have infrequent sex demonstrated a high degree of satisfaction and intent to use the method in the future. This aligns well with previous studies, which demonstrated demand and acceptability with a theoretical method (e.g., Chin-Quee, L'Engle, and Otterness 2014; Cover et al 2013a) and within actual study conditions (i.e., Festin et al 2016). Furthermore, women used the method as instructed, as their main form of contraception, and while the results were self-reported, repeat use appeared safe.…”

Feasibility of e-commerce pharmacy provision and acceptability of levonorgestrel 1.5 mg for pericoital use in urban and peri-urban settings in Kenya: a prospective cohort study

“…Moreover, more than a third (37%) of adopters obtained the study pill more than once, suggesting potential demand and acceptability of a pericoital FP method. Our findings are consistent with a previous study that showed high acceptability of LNG 1.5 mg for pericoital use in multiple countries: Hungary, Thailand, Singapore and Brazil 10. Furthermore, the study pill appeals to women having infrequent sex.…”

Feasibility and Acceptability of LNG 1.5 mg as an On‐Demand Pericoital Contraceptive in Ghana

“…This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al. 2016; Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al.…”

“…Furthermore, women used the method as instructed, as their main form of contraception, and while the results were self-reported, repeat use appeared safe. This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al 2016;Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al (2016) and was observed throughout this study.…”

“…This aligns well with the findings of previous studies on LNG 1.5 mg (e.g., Festin et al 2016;Halpern, Raymond, and Lopez 2014), where most side effects were mild or tolerable, they did not seem to impact satisfaction, and incidents were not clearly related to the frequency of use. A change in bleeding patterns was an expected outcome in Festin et al (2016) and was observed throughout this study. Bleeding had the highest average intensity of side effects reported, and the most frequently cited response for not liking the method was changes in their menstrual cycle.…”

“…Within the study, women who have infrequent sex demonstrated a high degree of satisfaction and intent to use the method in the future. This aligns well with previous studies, which demonstrated demand and acceptability with a theoretical method (e.g., Chin-Quee, L'Engle, and Otterness 2014; Cover et al 2013a) and within actual study conditions (i.e., Festin et al 2016). Furthermore, women used the method as instructed, as their main form of contraception, and while the results were self-reported, repeat use appeared safe.…”