Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
Participant gender:
Summary
This clinical trial determines if an oral medication taken within 2 days of anticipated
ovulation will delay ovulation by 7 days. The study compares oral placebo tablets (control)
to two oral study drugs, levonorgestrel a synthetic hormone and meloxicam a non-steroidal
anti-inflammatory drug (treatment) in 21 healthy women between the ages of 18 to 40. The
control or treatment are taken 48 hours apart in the first and second menstrual cycle,
respectively. The first dose is taken when the ovarian follicle has a diameter of 17 mm
measured by transvaginal ultrasound. This follicle diameter is found 2 ± 1.0 days before
ovulation. Ovulation is determined using a change in urinary hormone levels analyzed in first
morning daily urine. The Investigators anticipate that the control cycle will have an
interval to ovulation of ≤ 3 days from first placebo to ovulation while a delay of ≥7 days
will be found between first treatment to ovulation. A second question is to determine the
side effects between control versus treatment based on symptoms such as nausea or abdominal
cramping, change in blood pressure or pulse rate and the interval in menstrual bleeding.
Each study participant has approximately 9 visits during each of two menstrual cycles. The
visits between menstrual day 9 (first visit) to largest follicle are 3 to 6 depending upon
follicle growth. A blood sample with a transvaginal ultrasound for ovarian follicle diameter
is obtained at each visit. The appropriate medication is taken when the ovarian follicle
largest diameter is 17 mm. The second dose is taken 2 days later with interim and final
visits at 5 and 10 days following first dose. Each participant collects first morning urine
from menstrual day 9 to 23. A teaspoonful of morning urine is placed in a storage tube and
kept in a refrigerator freezer section until returned at a scheduled visit. All urine samples
are kept frozen until analyzed for the metabolites of estrogen and progesterone by a central
research laboratory. A change in the ratio of estrogen to progesterone metabolites is
indicative of ovulation because more progesterone is secreted after ovulation from the ovary.
The primary research outcome compares the interval in days from first dose of medication to
ovulation between control and treatment. Secondary outcomes are menstrual cramps, vaginal
bleeding, nausea, and headache, and changes in blood pressure, pulse, and interval between
menstrual periods in control compared to treatment cycles.
Phase:
Phase 2
Details
Lead Sponsor:
InnovaGyn, Inc.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)