Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
This study is an exploratory, prospective, multi‐center, randomized, cross‐over study to assess the effect of norgestrel 75 mcg on cervical mucus and ovarian activity during reported perfect daily use, after a delayed intake of 6 hours and after a missed pill. After a screening period up to one month, depending on the menstrual cycle of the subject, the subjects will take norgestrel 75 mcg for three 28‐day treatment periods, every day at the same time except for one day in the middle of treatment period 2 and treatment period 3 where they will either take it 6 hours late or not take it. In week 5 (1st visit of treatment period 2), they will be randomized to 2 sequences, either 6 hours delayed intake in treatment period 2 and missed pill in treatment period 3 or the opposite. After the end of treatment period 3, a follow‐up up to 12 days may be required to follow ovarian activities. Subjects will have visits twice a week and sometimes more often to assess the effects of the pill on: ‐ cervical mucus properties by a cervical mucus sampling ‐ ovarian activity by a vaginal ultrasound (TVUS) ‐ reproductive hormones levels by a blood sample (Progesterone (P4), Estradiol (E2), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH)) ‐ plasma drug level by a blood sample
Epistemonikos ID: c030735e8791d3ab6470d5d7ae6493e852f1f455
First added on: May 21, 2024