Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days

Conditions

• Pregnancy Prevention

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• Levonorgestrel 1.5mg — DRUG
  oral synthetic progesterone agonist
• Meloxicam 15 mg — DRUG
  Non steroidal autoinflammatory drug inhibiting both Cyclooxygenase -1 and -2 enzymes
• Placebo — OTHER
  Each tablet contains Calcium Carbonate 1000 mg

Study Details

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 oral 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 by 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 is 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.

Key Dates

Start date

Jun 28, 2022

Status verified

Aug 2025

Primary completion

Nov 30, 2025

Completion

Nov 30, 2025

Study Design

Enrollment

21 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo Comparator in Normal Ovulatory Women
  The two arm placebo comparator study will use each participant as her own control with a placebo arm in the first menstrual cycle consisting of two placebo tablets taken at the time of the ovarian follicle measuring 17 mm in diameter and a second dose of two tablets 48 hours later.
• Active Comparator: Active intervention in Normal Ovulatory Women
  The second menstrual cycle for each participant is an active intervention arm. Levonorgestrel 1.5 mg plus meloxicam 15 mg will be taken when the ovarian follicle reaches 17 mm in largest diameter. The two medications will be repeated 48 hours later.

Primary Outcome Measure

Interval to ovulation in normal women following placebo is 3 days compared to 7 days following levonorgestrel plus meloxicam [ Time Frame: The outcome will be assessed at the end of the first and second menstrual cycle of 28 ± 2.0 Days, respectively in up to two menstrual cycles. ]

Central Contacts

• David F. Archer, MD
  7574345864
  [email protected]
• William L. McPheat, PhD
  7573399048
  [email protected]

Locations (1)

Find similar trials in Raleigh, NC

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