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Phase II Study of Ovulation in Obese Women
NCT06306131 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG Levonorgestrel 0.15 milligram
- DRUG Meloxicam 15 milligram
- OTHER calcium carbonate 750 milligram
Study Locations (1)
North Carolina
- Carolina Women's Research and Wellness Center — Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-12-10 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06306131
The ClinicalTrials.gov registry entry for NCT06306131 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InnovaGyn, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pregnancy Prevention appearing as the primary indexed condition, and to 3 interventions — of which Levonorgestrel 0.15 milligram is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06306131 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06306131 about?
NCT06306131 is a clinical study titled "Phase II Study of Ovulation in Obese Women". 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 compar...
What is the current status of trial NCT06306131?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2023-12-10. Estimated completion is 2025-11-30.
What conditions does trial NCT06306131 study?
This clinical trial studies the following conditions: Pregnancy Prevention. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06306131?
The interventions under investigation include: Levonorgestrel 0.15 milligram (DRUG), Meloxicam 15 milligram (DRUG), calcium carbonate 750 milligram (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06306131?
This trial is sponsored by InnovaGyn, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06306131 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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