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
Conditions
Interventions
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
Sponsors
Foundation Consumer Healthcare (FCH)
Eligibility
Sex/Gender
All
Inclusion criteria
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 and completion of diary 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. Occurrence of regular menstrual cycles that typically happen 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. Both ovaries must be present. If both ovaries are not visible on the screening TVU, a confirmatory TVU may be performed on the same day or on a subsequent day within the Screening Visit allowance window. 8. Does not want to become pregnant during the study 9. Use of 1 of the accepted contraceptive regimens from the Screening Visit through to the end of the study. An acceptable method of contraception includes 1 of the following: · Abstinence from heterosexual intercourse · Intrauterine device (IUD; without hormones, i.e. copper IUD without drug release) · Male partner using condom with spermicide or male condom with use of a vaginal spermicide (gel, foam, or suppository) · Male partner vasectomized at least 6 months prior to the first study drug administration · Cervical cap with spermicide or · Female sterilization procedure 10. At least 1 bleeding episode consistent with menses must have occurred since last use, if the subject has recently used non-injectable hormonal contraception 11. Most recent injection must have occurred at least 6 months before the Pre-Screening Visit, and the subject must have had at least 1 normal menstrual cycle (2 consecutive menses), if there is a history of DepoProvera use 12. At least 2 menstrual bleeds must have occurred since the pregnancy ended, if the subject is postpartum or postabortal 13. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by the investigator 14. No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by the investigator 15. No clinically significant findings on the screening pelvic examination, as determined by the investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Currently lactating/breastfeeding or is within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding 2. Is pregnant according to the pregnancy test at screening or prior to the first study drug administration 3. Currently using any systemic contraceptives (e.g. oral, patch, vaginal ring, injections, implants or hormone-releasing IUD) or any hormone replacement therapy 4. Currently anovulatory (skipped ovulation) as confirmed by a midluteal P4 value of 3 units of alcohol per day, acute or chronic intake of excessive alcohol, or chronic daily use of marijuana) 13. Any clinically significant illness in the 28 days prior to the first study drug administration 14. Subjects who never had sexual intercourse 15. History of thrombophlebitis 16. Use of any prescription drugs (including all hormonal contraceptives and hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would interfere with the study treatment or put into question the status of the participant as healthy 17. Concomitant use of drugs and herbal products that induce enzymes that metabolize progestins (including cytochrome P450 3A4 [CYP3A4]) or treatment with human immunodeficiency virus (HIV) protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (Appendix 9) 18. Use of prescription nonsteroidal anti-inflammatory drug (NSAID) in the 28 days prior to the first study drug administration. For acute pain, acetaminophen, per product labeling (e.g. Tylenol) and over-the-counter (OTC) ibuprofen (no more than 200 mg every 6 hours) are allowed per product labeling. 19. Any history of tuberculosis 20. Positive test result for alcohol and/or drugs of abuse at screening or prior to each drug administration 21. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen (HBsAG (B) (hepatitis B)), or hepatitis C virus (HCV (C)) tests (if HIV Ag/Ab combo is positive, to be verified by Western Blot or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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 any spontaneously occurring luteinized unruptured follicle (LUF) 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 ;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);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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Captured time to ovulation in the treatment periods, if ovulation occurs. - Grade of ovarian activity - Differences in hormone levels between BMI groups, for each LNG dose level - If a follicle persists to form an LUF, this will be recorded and followed during all post-dosing visits where a TVU is performed for each LNG dose level - LNG (including total, free, and bioavailable) PK profiles across the different BMI groups, for each LNG dose level - Observed and reported AEs, significant changes in safety laboratory parameters, and vital signs;Timepoint(s) of evaluation of this end point: At various timepoints during the study as listed in Table 1 and 2 in the protocol | — |
Countries
United Kingdom, United States
Contacts
Public ContactPascale Servais
PPD
Outcome results
None listed