Effect of 1.5mg Levonorgesterel on ovulation inhibition in BMI groups
Research type
Research Study
Full title
An Open-label, Multi-center, Pharmacokinetic/Pharmacodynamic Study to Evaluate the Effect of a Single Dose of 1.5 mg Levonorgestrel-Emergency Contraception Tablet on Ovulation Inhibition, in relation to Body Mass Index on a Continuum from Underweight to Obese during Mid-follicular phase
IRAS ID
264097
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Gedeon Richter
Eudract number
2019-001143-43
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
This study will look at the effect of a single dose of a 1.5 mg Levonorgestrel-Emergency Contraception (LNG-EC) tablet on preventing ovulation (release of eggs from the ovaries) in relation to body mass index (BMI) on a range of women (from underweight to obese) during mid-follicular phase (the follicular phase is the time between the first day of the menstrual cycle and ovulation).
Levonorgestrel has been used as an emergency contraceptive for nearly 40 years and is authorized for sale in more than 100 countries worldwide. Studies conducted with levonorgestrel showed that the medication is effective in preventing unwanted pregnancies. The data regarding the effectiveness of the medication with increasing body weight or high BMI was unclear from these studies so this study will help in understanding if there is a relationship between the effectiveness of levonorgestrel emergency contraceptive in preventing ovulation and the participant’s BMI.
The study drug will be provided by the sponsor, or a delegate and participants will be given a single dose of the medication (1.5mg LNG-EC tablet), at the time of mid-follicular phase.
Approximately 400 healthy women, or women with chronic, stable disease treated with medications that do not interfere with Levonorgestrel or the ovulatory cycle, and within different age and BMI groups as set out in the study protocol are potentially eligible. An equal number of women are planned to be treated in each of 8 BMI categories.
The study will investigate differences in how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through and removed from the bodies (overall referred to as Pharmacokinetics) of women of differing weights/BMI. The study will also assess the time to ovulation from dosing, compare certain hormone levels and explore the effect of body weight on ovulatory suppression failure (ovulation, within 5 days from dosing) (overall referred to as Pharmacodynamics).
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/1282
Date of REC Opinion
7 Oct 2019
REC opinion
Further Information Favourable Opinion