Bioequivalence of 2 Levonorgestrel/Ethinyl Estradiol Formulations (N)

• Research type

  Research Study

• Full title

  An Open label, Single Dose, Randomised, 2-Way Crossover Bioequivalence Study between Two Tablet Formulations of 150 ug Levonorgestrel/30 ug Ethinyl Estradiol in Healthy Cycling Female Volunteers under Fasting Conditions

• IRAS ID

  34043

• Contact name

  Johnston Stewart

• Sponsor organisation

  Wyeth Medica Ireland

• Eudract number

  2009-014687-18

• Research summary

  Levonorgestrel (LNG) and ethinyl estradiol (EE) are synthetic forms of the female sex hormones progesterone and estrogen. Levonorgestrel/ethinyl estradiol (LNG/EE) is a combined treatment (containing 150 mcg LNG / 30 mcg EE) used for oral contraception, treatment of endometriosis (the name given to the condition where cells like the ones in the lining of the womb (uterus) are found elsewhere in the body), painful/heavy/irregular menstrual periods and premenstrual tension (PMT). It is also used in the treatment of abnormal uterine bleeding.Nordette© (manufactured by the study sponsor and being used as the comparison product in this study) is an approved combined oral contraceptive. Each tablet contains 150 mcg of levonorgestrel (LNG) and 30 mcg of ethinyl estradiol (EE).The study sponsor has developed a new LNG/EE contraceptive tablet containing the same amounts of LNG/EE as Nordette©. The 2 tablets differ in terms of how they are manufactured. Furthermore, the new tablet is film-coated whilst Nordette© is sugar coated.The purpose of this study is to find out how much of and the rate at which LNG and EE from the new tablet get into and are removed from the bloodstream when compared to the currently marketed tablet (Nordette©). A total of 28 menstruating female volunteers will take part in this study at one centre in the UK. Volunteers will be randomised to receive a single dose of each of the 2 study formulations during the course of the study. Volunteers will stay in the clinic on 2 separate occasions for 2.5 days and then return to the unit as an outpatient for 3 days. There will be an interval of at least 28 days between the 2 doses. The maximum duration of the study from screening until the final study visit could be up to 62 days for each volunteer.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/23

• Date of REC Opinion

  17 Dec 2009

• REC opinion

  Favourable Opinion