Novel On Demand Female Oral Contraceptive

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7. Project Summary/Abstract InnovaGyn, Inc. proposes to perform a Phase 2 Proof of Concept clinical trial in normal menstruating women between 18 to 40 years of age to demonstrate the ability of levonorgestrel plus meloxicam to delay ovulation by >7 days compared to placebo of <3 days. This is the beginning step in developing a novel On Demand female oral contraceptive. Most female hormonal contraceptives provide continuous exposure to exogenous hormones and are highly effective in preventing pregnancy. Female and male non-hormonal methods such as male and female condoms, spermicides, female diaphragms and withdrawal, are less effective and by interrupting the sex act diminish pleasure. Emergency contraception, used after unprotected intercourse, has a variable efficacy based on the time from intercourse to use and has an increased incidence of pregnancy with subsequent acts of intercourse. All female contraceptives have unique advantages and disadvantages and women are able to switch from one method to another depending upon their personal preferences and current life style. The average US woman uses four different contraceptive methods during her reproductive life. Women have indicated a need for a discreet, oral medication that can be taken with intercourse, that is effective and has limited side effects. InnovaGyn plans to develop a On Demand oral tablet to address this unmet need. Our product IG002 contains levonorgestrel, a progestin, plus meloxicam, a non-steroidal anti-inflammatory drug, that individually affect two important ovarian pathways involved in ovulation. Levonorgestrel inhibits the mid-cycle pituitary luteinizing hormone surge that results in ovulation. Meloxicam inhibits cyclooxygenase-2, an intrafollicular enzyme that is involved in creating the follicle wall tunnel where the oocyte (egg) is extruded at ovulation. The luteinizing hormone surge and subsequent intrafollicular events occur during the window of female fertility, the four days prior to and day of ovulation. Our product affects these two pathways increasing contraceptive efficacy by delaying ovulation beyond the 5 days of sperm fertilizing capacity. IG002 taken with intercourse can be used with repetitive acts of intercourse in a single menstrual cycle. This Pilot Study will evaluate the interval to ovulation following the first of two doses of placebo taken 48 hours apart administered 2 days before ovulation during the window of fertility. The same woman will take two doses of levonorgestrel plus meloxicam at the same time in a subsequent menstrual cycle. We anticipate that levonorgestrel plus meloxicam will delay ovulation >7 days compared to placebo <3 days. This is the first clinical trial to explore the efficacy of multiple doses of this combination medication in normal women using the collection of daily morning voided urines as a non-invasive method to assess changes in urinary estrone-3-glucuronide and pregnandiol-3- glucuronide, the luteal-follicular shift, as evidence of ovulation.