Study to evaluate the effect of oral BAF312 on a monophasic oral contraceptive in healthy female volunteers

INTERVENTION: Product Name: BAF312 0,25 mg tablet Product Code: BAF312 Pharmaceutical Form: Film‐coated tablet CAS Number: 1234627‐85‐0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25‐ Product Name: BAF312 1 mg tablet Product Code: BAF312 Pharmaceutical Form: Film‐coated tablet CAS Number: 1234627‐85‐0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Product Name: BAF312 4 mg tablet Product Code: BAF312 Pharmaceutical Form: Film‐coated tablet CAS Number: 1234627‐85‐0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ Trade Name: Microgynon Product Name: Microgynon Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: ETHINYLESTRADIOL CAS Number: 57‐63‐6 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30‐ CAS Number: 797‐63‐7 Other descriptive name: LEVONORGESTREL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.15‐ CONDITION: healthy volunteers (Multiple sclerosis is the intended indication for BAF312) ; Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: To investigate whether BAF312 administered daily at a dose of 4 mg can affect exposure (Cmax and AUC) to a daily monophasic oral contraceptive (OC) regimen containg 30 microgram ethinylestradiol (EE) and 150 microgram levonorgestrel (LVG). Primary end point(s): To investigate whether BAF312 administered daily at a dose of 4 mg can affect exposure (Cmax and AUC) to a daily administered monophasic oral contraceptive (OC) regimen containing 30 µg of ethinylestradiol (EE) and 150 µg of levonorgestrel (LVG). Secondary Objective: To assess the effect of oral BAF312 (4 mg q.d) on the pharmacodynamics of a monophasic OC determined by Hoogland score, FSH, LH, estradiol, progesterone, SHBG concentrations and ovarian follicle size.; To assess the safety and tolerabililty of oral BAF312 (4 mg q.d.) in co‐administration with a monophasic OC.; To assess the PK profile of oral BAF312 (4 mg q.d.) when combined with a daily administered monophasic OC regimen containing 30 microgram of EE and 150 microgram of LVG Timepoint(s) of evaluation of this end point: Specified on page 16/17 of the protocol SECONDARY OUTCOME: Secondary end point(s): To assess the effect of oral BAF312 (4 mg q.d.) on the pharmacodynamics of a monophasic OC determined by Hoogland score, FSH, LH, estradiol, progesterone,SHBG concentrations and ovarian follicle size; • To assess the safety and tolerability of oral BAF312 (4 mg q.d.) in co‐administration with a monophasic OC, ; • To assess the PK profile of oral BAF312 (4 mg q.d.) when combined with a daily administered monophasic oral contraceptive (OC) regimen containing 30 µg of EE and 150 µg of LVG. Timepoint(s) of evaluation of this end point: Specified on page 16/17 of the protocol INCLUSION CRITERIA: 1. written IC 2. healthy females of childbearing potential 18‐40 years + in good health as determined by past medical history, physical examination, vital signs, ECG, 24 h Holter and lab tests, PAP smear, gynecological exam. and transvaginal ultrasound before dosing in period 1 3. Stable regimen of monophasic OC containing EE (30 microgram)/LVG (150 microgram) as for at least three cycles prior to dosing in period 1 and willing to undergo synchronization of at least one cycle until day ‐7. Any subject not taking any OC or taking another brand of monophasic OC should be willing to take monophasic OC containing EE 30 microgram and LVG 150 microgram for at least three cycles during synchronization until day ‐7.Willing to continue OC until at least 30 d after study completion 4. negative pregnancy test results at screening and baseline 1 5. willing to use additional, non‐hormonal contraception from screening until 30 days after study completion. 6. w