Randomized, Open-Label, Multicenter Proof-of-Principle Study to Assess the Effect of Single Doses of 1.5 mg and 3.0 mg Levonorgestrel During the Mid-Follicular Phase on the Inhibition of Ovulation in Women Across Body Mass Index Categories

INTERVENTION: Trade Name: Levonorgestrel 1.5 mg Tablet (Authorized Generic) Product Name: Levonorgestrel 1.5 mg Tablet (Authorized Generic) Pharmaceutical Form: Tablet INN or Proposed INN: Levonorgestrel CAS Number: 797‐63‐7 Current Sponsor code: LNG‐EC Other descriptive name: LEVONORGESTREL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5‐ CONDITION: Inhibition of Ovulation in Women Across Body Weight Categories During the Mid‐Follicular Phase ; MedDRA version: 22.0 Level: LLT Classification code 10082354 Term: Emergency contraceptive pill System Organ Class: 100000004865 Therapeutic area: Body processes [G] ‐ Reproductive physiologi cal processes [G08] PRIMARY OUTCOME: Main Objective: · To evaluate the possibility that inhibition of ovulation is affected by BMI in women using the current dose of 1.5 mg LNG‐EC; · To evaluate the effect of the 3.0mg LNG EC dose on inhibition of ovulation response across each of the BMI groups Primary end point(s): ‐ Ovulation suppression (i.e. no occurrence of follicular rupture) within 5 days from LNG treatment administration, across each of the BMI groups (for each LNG dose level); ‐ Ovulatory dysfunction (i.e. follicle rupture not preceded within 48 hours by a luteinizing hormone (LH) peak >21 IU/L), and/or followed by a luteal phase P4 peak of >3 ng/mL), across each of the BMI groups (for each LNG dose level) Secondary Objective: ‐ To evaluate the possibility that the ovarian activity is affected by BMI in women using LNG‐EC; ‐ To assess hormone levels between BMI groups at each LNG dose level; ‐ To evaluate differences in the pharmacokinetics of LNG‐EC between different BMI groups; ‐ To assess the safety and tolerability for each LNG dose level Timepoint(s) of evaluation of this end point: At various timepoints during the study as listed in Table 1 and 2 in the protocol SECONDARY OUTCOME: Secondary end point(s): ‐ Captured time to ovulation in the treatment cycles, if ovulation occurs. ; ‐ Grade of ovarian activity ; ‐ Differences in hormone levels between BMI groups, for each LNG dose level ; ‐ LNG (including total, free, and bioavailable) PK profiles across the different BMI groups, for each LNG dose level Timepoint(s) of evaluation of this end point: At various timepoints during the study as listed in Table 1 and 2 in the protocol INCLUSION CRITERIA: 1. Provision of signed and dated ICF 2. Stated willingness to comply with all study procedures including attendance at the study center for all study visits as scheduled 3. Healthy adult, ovulatory female 4. Aged at least 18 years but not older than 40 years 5. Non‐ or ex‐smoker (An ex‐smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration) 6. Has regular menstrual cycles that typically occur every 24‐35 days when not using hormonal contraception (established by medical history over the past 3 months) and that should preferably be of consistent duration within this range. In addition, subject must have a midluteal P4 value of =12 nmol/L to confirm baseline ovulatory status during the screening visit 7. Has both ovaries visible on the screening TVU scan. Polycystic ovaries detected by TVU are not exclusionary if subject is ovulatory (refer to inclusion