Effect of 1.5/3.0 mg Levonorgestrel on Ovulation Inhibition in BMI
Research type
Research Study
Full title
Randomized, Open-Label, Multicenter Proof-of-Principle Study to Assess the Effect of Single Doses of 1.5 mg and 3.0 mg Levonorgestrel (LNG) During the Mid-Follicular Phase on the Inhibition of Ovulation in Women Across Mass Index Categories
IRAS ID
282039
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Foundation Consumer Healthcare (FCH)
Eudract number
2020-000089-41
Duration of Study in the UK
1 years, 0 months, 16 days
Research summary
This is a multi-centre, randomised, open label, crossover pharmacokinetic(PK)/pharmacodynamic(PD) study.
The study will evaluate the possibility that inhibition of ovulation is affected by body mass index (BMI) in women using the current dose of 1.5 mg Levonorgestrel-Emergency Contraception (LNG-EC). The study will also evaluate the effect of the 3.0 mg LNG EC dose on inhibition of ovulation response across each of the BMI groups.
The study will enrol 150 healthy ovulatory female participants aged 18 to 40 years.
The 150 participants will comprise of:
• 30 underweight/normal participants (BMI < 18.5 to < 25 kg/m2)
• 60 overweight participants (BMI 25 to < 30 kg/m2)
• 60 obese participants (40 with obesity Class I [30 ≤ BMI < 35 kg/m2], 10 with Obesity Class II [35 ≤ BMI < 40 kg/m2] and 10 with Obesity Class III [40 kg/m2 < BMI]The study comprises of an initial (telephone) contact, Pre-Screening Visit to sign consent should it be necessary to wash out of any contraceptives or other excluded medication, a Screening Visit, 2 Treatment Cycles (each consisting of 1 overnight stay) separated by one or two Wash-Out Cycles, and a Follow-Up Call.
The 2 doses of LNG (single 1.5 mg dose and single 3 mg dose) to be studied will be randomly assigned such that each dose level will be given once over the 2 treatment periods. Each of the 2 treatment sequences will include 3 BMI groups with a ratio of 1:2:2 (15 underweight/normal, 30 overweight and 30 obese participants).
Each study drug will be administered once, at the time when the follicle diameter is 14 to 16 mm.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0115
Date of REC Opinion
26 May 2020
REC opinion
Further Information Favourable Opinion