NCT06306131

Phase II Study of Ovulation in Obese Women

A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: InnovaGyn, Inc. · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are: 1. Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo. 2. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments \[placebo versus levonorgestrel plus meloxicam\]. Participants will: * undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam, * maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding, * collect daily first morning voided urine from menstrual day 9 to 24, * undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14. * allow a blood sample to be drawn on days with ultrasound scans. * Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later. Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs

Detailed description

We will perform a single site clinical trial in obese women not at risk of pregnancy aged 18 to 40. We will screen to enroll and complete 22 participants. Each participant after signing an Informed Consent and meeting all inclusion and exclusion criteria will be enrolled on menstrual day 9-10 of a subsequent menstrual cycle following a negative urine pregnancy test. Each participant will be asked to collect a first morning voided urine sample beginning on menstrual day 9 and completing 15 days later on menstrual day 24. The participant will undergo a transvaginal ultrasound on menstrual days 9-10, 12, 13 and day 14 to determine ovarian follicle diameters in two planes frontal and sagittal using transvaginal ultrasound. When the largest follicle diameter is 17±1.0 millimeters (mm) the participant will be given the intervention: placebo in the 1st cycle and levonorgestrel plus meloxicam in the 2nd cycle followed by a second dose of each intervention 48 hours later. The ovarian follicle dimension of 17 mm occurs in the middle of the woman's window of fertility which is the four days preceding plus the day of ovulation. We anticipate that ovulation will take place within 3 days after the first placebo dose in 90% of the participants and will be delayed ≥7 days following the first dose of levonorgestrel plus meloxicam in ≥80% of the participants. The primary outcome is the delay in days from the first dose to evidence of ovarian corpus luteum formation which follows ovulation. All urine samples from the same participant will be analyzed in one assay for estrogen and progesterone metabolites to reduce inter-assay variability. The primary outcome will be delay of ovulation based on changes in the ratio of the urinary metabolites in obese women between placebo and active treatment. Secondary outcomes (exploratory) are a) safety parameters vital signs consisting of blood pressure and pulse obtained at each visit, b) adverse events, unscheduled bleeding, and changes in menstrual bleeding captured by the participant using a daily diary card. She will be instructed to write down any symptoms or problem along with medication taken both study drug and any other medication. Any treatment adverse event considered to be serious will be reported to the local institutional review board and the Food and Drug Administrating within 72 hours of our being made aware of the problem. The occurrence, percentage, and relationship to study drug of minor and moderate adverse events will be noted and categorized using Medical Dictionary for Regulatory Activates (MedRA) adverse event classification and listed in all reports and publications. Each participant will be involved for a study period of approximately 2.5 months or 75 days. Each participant will undergo a complete history and physical evaluation at entry and a brief interim history and physical evaluation at exit with height and weight at entry. Mean and standard deviation of all vital signs before and after treatment, menstrual bleeding changes and treatment emergent adverse events will be compiled and listed in all reports and publications.

Conditions

• Pregnancy Prevention

Interventions

Type	Name	Description
DRUG	Levonorgestrel 0.15 milligram	The study design is an open label randomized single blind clinical trial in which each participant will receive placebo two tablets 48 hours apart in their first menstrual cycle and then levonorgestrel plus meloxicam 48 hours apart in their subsequent menstrual cycle. We will compare the interval from taking the first dose of medication to the development of a functioning corpus luteum based on the shift in the ratio of urinary estrone-3-glucuronide(EC) / pregnanediol-3-glucuronide (PDG).
DRUG	Meloxicam 15 milligram	The study design is an open label randomized single blind clinical trial in which each participant will receive placebo two tablets 48 hours apart in their first menstrual cycle and then levonorgestrel plus meloxicam 48 hours apart in their subsequent menstrual cycle. We will compare the interval from taking the first dose of medication to the development of a functioning corpus luteum based on the shift in the ratio of urinary estrone-3-glucuronide(EC) / pregnanediol-3-glucuronide (PDG).
OTHER	calcium carbonate 750 milligram	The study design is an open label randomized single blind clinical trial in which each participant will receive placebo two tablets 48 hours apart in their first menstrual cycle and then levonorgestrel plus meloxicam 48 hours apart in their subsequent menstrual cycle. We will compare the interval from taking the first dose of medication to the development of a functioning corpus luteum based on the shift in the ratio of urinary estrone-3-glucuronide(EC) / pregnanediol-3-glucuronide (PDG).

Timeline

• Start date: 2023-12-10
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2024-03-12
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study