protocolSection identificationModule nctId: NCT06306131, orgStudyIdInfo id: IG-23-002, secondaryIdInfos id: 1R43HD107861-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R43HD107861-01A1, briefTitle: Phase II Study of Ovulation in Obese Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-10, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: InnovaGyn, Inc., class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: 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, conditionsModule conditions: Pregnancy Prevention, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Placebo controlled in first cycle with levonorgestrel plus meloxicam in second menstrual cycle., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: The intervention will be masked to the laboratory preforming the analysis of the urinary metabolites. The statistician, clinicians, coordinators and participants will be aware of the medication being studied., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Levonorgestrel 0.15 milligram, interventions name: Meloxicam 15 milligram, interventions name: calcium carbonate 750 milligram, outcomesModule primaryOutcomes measure: Interval from first dose to evidence of ovulation., secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in Pulse, otherOutcomes measure: Unscheduled endometrial bleeding and changes in interval, amount and duration of menstrual bleeding., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Carolina Women's Research and Wellness Center, status: RECRUITING, city: Raleigh, state: North Carolina, zip: 27713, country: United States, contacts name: Andrea S. Lukes, MD, role: CONTACT, phone: 919-251-9223, email: andrealukes@cwrwc.com, contacts name: Janet F. Davis, role: CONTACT, phone: 9192519223, email: janet@cwrwc.com, contacts name: Andrea S. Lukes, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.7721, lon: -78.63861, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-04-17, uploadDate: 2023-10-16T10:12, filename: ICF_000.pdf, size: 336680, hasResults: False