NCT03585712

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

A Prospective, Multi-center, Randomized, Cross-over Study to Assess the Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: HRA Pharma · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Norgestrel 75 mcg is a progestin-only pill (POP), which is a kind of oral birth control pill. To be effective in preventing pregnancy, this kind of birth control pill is supposed to be taken every day at the same time, without delaying the intake for more than 3 hours. This study aims to find out if taking the pill 6 hours late or not taking it for one day will affect the way it works.

Detailed description

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

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Norgestrel 0.075 mg	Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3

Timeline

• Start date: 2018-07-24
• Primary completion: 2020-04-07
• Completion: 2020-04-07
• First posted: 2018-07-13
• Last updated: 2021-06-03
• Results posted: 2021-06-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study