TY - JOUR
T1 - The effect of deliberate non-adherence to a norgestrel progestin-only pill
T2 - A randomized, crossover study
AU - Glasier, Anna
AU - Edelman, Alison
AU - Creinin, Mitchell D.
AU - Brache, Vivian
AU - Westhoff, Carolyn L.
AU - Han, Leo
AU - Chen, Melissa J.
AU - Hemon, Agnes
N1 - Funding Information:
Conflicts of interest: AG acts as an independent, paid, medical consultant to HRA Pharma and has consulted for Medincell, France. AE receives royalties from Up to Date, Inc. Oregon Health & Science University receives research funding from OHSU Foundation, Merck, HRA Pharma, and NIH where AE is the principal investigator. MDC has received speaking honorarium from Gedeon Richter and Mayne, serves on Advisory Boards for Fuji Pharma and GlaxoSmithKline, and is a consultant for Estetra SRL, Libbs, Mayne, and Medicines360. The Department of Obstetrics and Gynecology, University of California, Davis, receives contraceptive research funding for MDC from Chemo Research SL, Evofem, Medicines360, Merck, and Sebela. VB reports no conflicts.CLW receives honoraria from Merck and Bayer as a DSMB member and has been an independent paid consultant to HRA Pharma. Columbia University receives research funding from Medicines360, Sebela, and Chemo Research SL.
Funding Information:
Funding: The study was funded by HRA-Pharma, Chatillon, France . The study was designed by the sponsor in discussion with the independent medical advisor (AG). The protocol was finalized after discussions of the feasibility and practical details with the principal investigators at the two sites (AE, MC). The authors have had unfettered access to all the data and have analyzed them independently in preparing this paper. The sponsor has had no involvement in the decision to submit the report for publication.
Publisher Copyright:
© 2022
PY - 2023/1
Y1 - 2023/1
N2 - Objectives: To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill. Study design: In a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.0 kg/m² and regular ovulatory cycles completed a baseline 28-day cycle with correct daily pill use followed by two intervention cycles in which, around mid-cycle, one pill was taken 6 hours late or missed completely. We undertook ovarian ultrasonography, estradiol and progesterone measurement, and cervical mucus assessments every 3 to 4 days (daily around the time of the incorrect use) and based the theoretical contraceptive protection score on ovarian activity status, cervical mucus and their temporal relationship. Results: Of 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility. Conclusions: Delayed or missed intake of a single norgestrel 0.075 mg progestogen-only pill appears to have little effect on theoretical contraceptive efficacy. Implications: This biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.
AB - Objectives: To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill. Study design: In a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.0 kg/m² and regular ovulatory cycles completed a baseline 28-day cycle with correct daily pill use followed by two intervention cycles in which, around mid-cycle, one pill was taken 6 hours late or missed completely. We undertook ovarian ultrasonography, estradiol and progesterone measurement, and cervical mucus assessments every 3 to 4 days (daily around the time of the incorrect use) and based the theoretical contraceptive protection score on ovarian activity status, cervical mucus and their temporal relationship. Results: Of 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility. Conclusions: Delayed or missed intake of a single norgestrel 0.075 mg progestogen-only pill appears to have little effect on theoretical contraceptive efficacy. Implications: This biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.
KW - Adherence
KW - Cervical mucus
KW - Missed pill
KW - Norgestrel 0.075 mg
KW - Ovulation
KW - Progestogen-only pill
UR - http://www.scopus.com/inward/record.url?scp=85140928514&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85140928514&partnerID=8YFLogxK
U2 - 10.1016/j.contraception.2022.09.002
DO - 10.1016/j.contraception.2022.09.002
M3 - Article
C2 - 36130667
AN - SCOPUS:85140928514
SN - 0010-7824
VL - 117
SP - 1
EP - 6
JO - Contraception
JF - Contraception
ER -