Pregnancy PreventionPhase 2NCT06306131
Phase II Study of Ovulation in Obese Women
A Phase 2 study testing Levonorgestrel 1.5 milligram, Meloxicam 15 milligram and calcium carbonate 750 milligram in people with Pregnancy Prevention, run by InnovaGyn, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Prevention
- What is being tested?
- Levonorgestrel 1.5 milligram, Meloxicam 15 milligram and calcium carbonate 750 milligram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2023to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female in good general health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
- Age between 18 to 40 years inclusive at time of enrollment.
- BMI ≥30 kg/m² and no recent rapid weight loss or gain.
- Intact uterus with both ovaries intact.
- Papanicolaou test within American Society for Colposcopy and Cervical Pathology (ASCCP), or American College of Obstetricians and Gynecologists (ACOG) guidelines such that additional testing or evaluation will not be required during the study period. If there is no copy of a recent Papanicolaou test and the subject is 21 years or older a Papanicolaou test should be done during the screening visit.
- Regular menstrual cycles with an interval of 24 to 32 days:
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- If postpartum or post-second trimester abortion, she must have 2 spontaneous menses prior to enrollment.
- If the subject has had a first trimester pregnancy loss or abortion, she must have one spontaneous menses prior to enrollment.
- Have a negative urine pregnancy test on menstrual cycle day 9 pre-treatment visit.
- Not at risk of pregnancy for the duration of the study defined as heterosexually abstinent, prior female or male permanent contraception, non-hormonal intrauterine device or willing to use a non-hormonal barrier contraceptive method with each act of intercourse until study exit.
- Subject is willing and able in the Investigators opinion of complying with protocol requirements.
- Subject is willing to collect daily first morning urines and store them until brought to the study site.
- Lives within the study catchment area or a reasonable distance from the study site.
- Understands and signs the IRB approved informed consent prior to undergoing any screening assessment.
- Agrees not to participate in any other clinical trials during the course of this study.
- Screening serum progesterone level greater than 3 ng/ml.-
Who cannot join
- Known hypersensitivity or contraindications to progestins.
- Abnormal transvaginal ultrasound or safety laboratory results evaluated during the screening period recognized as clinically significant by the investigator or medically qualified designee.
- Known or suspected alcohol or marijuana abuse.
- Undiagnosed abnormal genital bleeding.
- Undiagnosed vaginal discharge, lesions or abnormalities.
- Women with a history of genital herpes can be included if the outbreaks are infrequent. Antiviral prophylaxis is allowed.
Show all 35Show fewer
- Uncontrolled Thyroid disorder.
- Current use of hormonal contraception or a levonorgestrel releasing intrauterine device.
- Use of a long-acting injectable hormonal contraceptive within the past 6 months unless has had at least one spontaneous menstrual cycle (two menstrual bleeding episodes) since the last injection.
- Breastfeeding women or those who have not had a spontaneous menstrual bleed since discontinuing breastfeeding.
- Women who plan a major surgical procedure during the study.
- Women who plan to become pregnant during their participation in the study.
- Women who smoke >15 cigarettes per day or who use >1 mL/day of nicotine-containing liquid for electronic cigarettes.
- Current or history of ischemic heart disease or stroke while pregnant or during use of hormonal contraception.
- Current or past deep vein thrombosis or thromboembolic disorder.
- Personal or family history of thrombophilia
- History of retinal vascular lesions or partial or complete loss of vision.
- Known or suspected carcinoma of the breast, endometrium, or other suspected progestin sensitive neoplasia.
- History of other carcinomas excluding basal cell cancers unless in remission for > 5 years.
- Current or past medically diagnosed severe depression unless the potential participant is on stable medication or in the opinion of the Principal Investigator could be exacerbated using a hormonal contraceptive.
- History of headaches with focal neurologic symptoms.
- Have a current need for exogenous hormones or therapeutic anticoagulants.
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid hormone use.
- Other benign or malignant liver tumors or active liver disease.
- Systolic BP ≥145 mm Hg and/or diastolic BP ≥96 mm Hg after 5 -10 minutes of rest in a sitting position. If the initial BP values are above these cut-offs, a total of 3 measurements may be taken and the results averaged. If the averaged BP is below the cut-off levels, the participant may be allowed into the study. Hypertension that is treated and controlled may be allowed based on the Investigator's discretion.
- Clinically significant abnormal serum chemistry value based on the Investigator's judgement.
- Participation in another clinical trial involving an investigational drug or device within the past two months before anticipated enrollment or is planning to participate in another clinical study during this study.
- Use of any liver enzyme inducers or plans to use such medication during the study.
- Known HIV infection.
- History of a gastrointestinal ulcer or bleeding.
- Women who are using medication on the Exclusionary medication list (See Appendix).
- Have issues or concerns, in the opinion of the Investigator, that may compromise the study or confound the reliability of compliance and information that is required in this study.
- Have a known hypersensitivity to either levonorgestrel or a non-steroidal anti-inflammatory drug.
- Use of any medication that could interfere with the metabolism of a hormonal contraceptive or the non-steroidal anti-inflammatory drugs or any drug that falls in FDA Pregnancy and Lactation narrative subsections (Formerly Category D or X medications).
- Be a site member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member who will be delegated study responsibilities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Women's Research and Wellness Center
Raleigh, North Carolina, 27713
About this study
Official title: A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating 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:
- 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.
- There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments [placebo versus levonorgestrel plus meloxicam].
Read more
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
Read the 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
- Being tested
- Levonorgestrel 1.5 milligram, Meloxicam 15 milligram, calcium carbonate 750 milligram
- Keywords
- Female, Hormonal contraception, Emergency Contraception, levonorgestrel, meloxicam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel 1.5 milligramDrug
Also called Plan B one Step
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).
Meloxicam 15 milligramDrug
Also called Mobic
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).
calcium carbonate 750 milligramOther
Also called TUMS
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo is calcium carbonate 750 milligram (mg) known as TUMS. Each participant will take one tablet orally and repeat 48 hours later. Receives: Other: calcium carbonate 750 milligram |
| Levonorgestrel plus meloxicam | Active comparator | The active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later. Receives: Drug: Levonorgestrel 1.5 milligram; Drug: Meloxicam 15 milligram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval From First Dose to Evidence of Ovulation.
An ovarian follicle diameter of 17 mm is used to take the first dose of medication. Daily morning urine samples were analyzed for pregnanediol-3-glucuronide (PDG) and creatinine. A 100% increase in urinary PDG levels was used to indicate day of ovulation, the follicular luteal shift. The interval from first dose of placebo (calcium carbonate) to follicular luteal shift is estimated to be 3 days. The active treatment (levonorgestrel 1.5 mg and meloxicam 15 mg) will be given the following month when the ovarian follicle diameter is also 17 mm. The outcome is estimated to be a delay of 7 + days from 1st dose to the follicular luteal shift or ovulation with the active treatment. Urinary PDG values were assessed to 10 days from first dose of both placebo and active treatment.
Measured: The interval is estimated to be 3 days from first dose of placebo to evidence of ovulation, and the interval is estimated to be 7 days from first dose of intervention to evidence of ovulation. Assessment was to 10 days from first dose.
Secondary outcomes (2)
Change in Pulse Rate. The Measured Pulse Rate From the Day of the First Dose Minus the Pulse Rate Measured 10 Days From the First Dose.
Pulse measured in beats per minute at the wrist was measured on day of the first dose and compared to pulse measured 10 days from the first dose in both the placebo and intervention cycles. The change in pulse rate was determined by subtracting the pulse rate 10 days from the first dose from the pulse rate measured on the day of the first dose. If the number is negative that indicates that the pulse rate from the visit 10 days from the first dose was higher than the pulse measured on the day of the first dose.
Measured: Pulse rate is measured at all clinic visits during each menstrual cycle but only the day of first dose and 10 days from first dose was used for this outcome measure.
Change in Blood Pressure. The Measured Blood Pressure From the Day of the First Dose Minus the Blood Pressure Measured 10 Days From the First Dose.
Sitting blood pressure in millimeters mercury (mm Hg) will be compared between the day of the first dose and ten days from the first dose of both the placebo and active treatment cycles. The change in blood pressure was determined by subtracting the blood pressure 10 days from the first dose from the blood pressure measured on the day of the first dose. If the number is negative that indicates that the blood pressure from the visit 10 days from the first dose was higher than the blood pressure measured on the day of the first dose.
Measured: Blood pressure is measured at all clinic visits during each menstrual cycle but only the day of first dose and 10 days from first dose was used for this outcome measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start10 Dec 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Placebo controlled in first cycle with levonorgestrel plus meloxicam in second menstrual cycle.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnovaGyn, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Andrea Lukes, MD, Principal investigator, Carolina Woman's Research and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306131
- Sponsor's protocol ID
- IG-23-002
- Other IDs
- 1R43HD107861-01A1
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2023
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raymond EG, Shochet T, Drake JK, Westley E. What some women want? On-demand oral contraception. Contraception. 2014 Aug;90(2):105-10. doi: 10.1016/j.contraception.2014.04.008. Epub 2014 Apr 21.
PubMed 24835831Daniels K, Mosher WD. Contraceptive methods women have ever used: United States, 1982-2010. Natl Health Stat Report. 2013 Feb 14;(62):1-15.
PubMed 24988816Moreau C, Cleland K, Trussell J. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception. 2007 Oct;76(4):267-72. doi: 10.1016/j.contraception.2007.06.008. Epub 2007 Aug 28.
PubMed 17900435Trussell J. Contraceptive failure in the United States. Contraception. 2004 Aug;70(2):89-96. doi: 10.1016/j.contraception.2004.03.009.
PubMed 15288211Simmons RG, Sanders JN, Geist C, Gawron L, Myers K, Turok DK. Predictors of contraceptive switching and discontinuation within the first 6 months of use among Highly Effective Reversible Contraceptive Initiative Salt Lake study participants. Am J Obstet Gynecol. 2019 Apr;220(4):376.e1-376.e12. doi: 10.1016/j.ajog.2018.12.022. Epub 2018 Dec 18.
PubMed 30576664Venners SA, Liu X, Perry MJ, Korrick SA, Li Z, Yang F, Yang J, Lasley BL, Xu X, Wang X. Urinary estrogen and progesterone metabolite concentrations in menstrual cycles of fertile women with non-conception, early pregnancy loss or clinical pregnancy. Hum Reprod. 2006 Sep;21(9):2272-80. doi: 10.1093/humrep/del187. Epub 2006 Jun 23.
PubMed 16798842Bradley SEK, Polis CB, Bankole A, Croft T. Global Contraceptive Failure Rates: Who Is Most at Risk? Stud Fam Plann. 2019 Mar;50(1):3-24. doi: 10.1111/sifp.12085. Epub 2019 Feb 21.
PubMed 30791104Pace LE, Dusetzina SB, Keating NL. Early Impact Of The Affordable Care Act On Oral Contraceptive Cost Sharing, Discontinuation, And Nonadherence. Health Aff (Millwood). 2016 Sep 1;35(9):1616-24. doi: 10.1377/hlthaff.2015.1624.
PubMed 27605641Duffy DM, Ko C, Jo M, Brannstrom M, Curry TE. Ovulation: Parallels With Inflammatory Processes. Endocr Rev. 2019 Apr 1;40(2):369-416. doi: 10.1210/er.2018-00075.
PubMed 30496379Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, Massai R, Faundes A, Salvatierra AM. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception. 2004 Dec;70(6):442-50. doi: 10.1016/j.contraception.2004.05.007.
PubMed 15541405Devoto L, Fuentes A, Palomino A, Espinoza A, Kohen P, Ranta S, von Hertzen H. Pharmacokinetics and endometrial tissue levels of levonorgestrel after administration of a single 1.5-mg dose by the oral and vaginal route. Fertil Steril. 2005 Jul;84(1):46-51. doi: 10.1016/j.fertnstert.2005.01.106.
PubMed 16009156Brache V, Cochon L, Deniaud M, Croxatto HB. Ulipristal acetate prevents ovulation more effectively than levonorgestrel: analysis of pooled data from three randomized trials of emergency contraception regimens. Contraception. 2013 Nov;88(5):611-8. doi: 10.1016/j.contraception.2013.05.010. Epub 2013 May 22.
PubMed 23809278Duffy DM. Novel contraceptive targets to inhibit ovulation: the prostaglandin E2 pathway. Hum Reprod Update. 2015 Sep-Oct;21(5):652-70. doi: 10.1093/humupd/dmv026. Epub 2015 May 29.
PubMed 26025453Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.
PubMed 21920190Glasier A. Emergency contraception: clinical outcomes. Contraception. 2013 Mar;87(3):309-13. doi: 10.1016/j.contraception.2012.08.027. Epub 2012 Oct 4.
PubMed 23040128
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women
- ClinicalTrials.gov ID
- NCT06306131
- Acronym / sponsor ID
- IG-23-002
- Conditions
- Pregnancy Prevention
- Keywords
- Female, Hormonal contraception, Emergency Contraception, levonorgestrel, meloxicam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- InnovaGyn, Inc.University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled in first cycle with levonorgestrel plus meloxicam in second menstrual cycle.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: calcium carbonate 750 milligramThe placebo is calcium carbonate 750 milligram (mg) known as TUMS. Each participant will take one tablet orally and repeat 48 hours later. |
| Levonorgestrel plus meloxicam | Active comparator | Drug: Levonorgestrel 1.5 milligram, Drug: Meloxicam 15 milligramThe active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Female in good general health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
- Age between 18 to 40 years inclusive at time of enrollment.
- BMI ≥30 kg/m² and no recent rapid weight loss or gain.
- Intact uterus with both ovaries intact.
- Papanicolaou test within American Society for Colposcopy and Cervical Pathology (ASCCP), or American College of Obstetricians and Gynecologists (ACOG) guidelines such that additional testing or evaluation will not be required during the study period. If there is no copy of a recent Papanicolaou test and the subject is 21 years or older a Papanicolaou test should be done during the screening visit.
Key exclusion criteria (35 listed)
- Known hypersensitivity or contraindications to progestins.
- Abnormal transvaginal ultrasound or safety laboratory results evaluated during the screening period recognized as clinically significant by the investigator or medically qualified designee.
- Known or suspected alcohol or marijuana abuse.
- Undiagnosed abnormal genital bleeding.
- Undiagnosed vaginal discharge, lesions or abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel 1.5 milligramAlso: Plan B one StepThe 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 | Levonorgestrel plus meloxicam |
| Meloxicam 15 milligramAlso: MobicThe 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 | Levonorgestrel plus meloxicam |
| calcium carbonate 750 milligramAlso: TUMSThe 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 | Placebo |
Primary outcome
Interval From First Dose to Evidence of Ovulation.
Time frame: The interval is estimated to be 3 days from first dose of placebo to evidence of ovulation, and the interval is estimated to be 7 days from first dose of intervention to evidence of ovulation. Assessment was to 10 days from first dose.
An ovarian follicle diameter of 17 mm is used to take the first dose of medication. Daily morning urine samples were analyzed for pregnanediol-3-glucuronide (PDG) and creatinine. A 100% increase in urinary PDG levels was used to indicate day of ovulation, the follicular luteal shift. The interval from first dose of placebo (calcium carbonate) to follicular luteal shift is estimated to be 3 days. The active treatment (levonorgestrel 1.5 mg and meloxicam 15 mg) will be given the following month when the ovarian follicle diameter is also 17 mm. The outcome is estimated to be a delay of 7 + days from 1st dose to the follicular luteal shift or ovulation with the active treatment. Urinary PDG values were assessed to 10 days from first dose of both placebo and active treatment.
2 secondary outcomes
Change in Pulse Rate. The Measured Pulse Rate From the Day of the First Dose Minus the Pulse Rate Measured 10 Days From the First Dose.
Time frame: Pulse rate is measured at all clinic visits during each menstrual cycle but only the day of first dose and 10 days from first dose was used for this outcome measure.
Change in Blood Pressure. The Measured Blood Pressure From the Day of the First Dose Minus the Blood Pressure Measured 10 Days From the First Dose.
Time frame: Blood pressure is measured at all clinic visits during each menstrual cycle but only the day of first dose and 10 days from first dose was used for this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24835831Raymond EG, Shochet T, Drake JK, Westley E. What some women want? On-demand oral contraception. Contraception. 2014 Aug;90(2):105-10. doi: 10.1016/j.contraception.2014.04.008. Epub 2014 Apr 21.
- Background: PubMed 24988816Daniels K, Mosher WD. Contraceptive methods women have ever used: United States, 1982-2010. Natl Health Stat Report. 2013 Feb 14;(62):1-15.
- Background: PubMed 17900435Moreau C, Cleland K, Trussell J. Contraceptive discontinuation attributed to method dissatisfaction in the United States. Contraception. 2007 Oct;76(4):267-72. doi: 10.1016/j.contraception.2007.06.008. Epub 2007 Aug 28.
- Background: PubMed 15288211Trussell J. Contraceptive failure in the United States. Contraception. 2004 Aug;70(2):89-96. doi: 10.1016/j.contraception.2004.03.009.
- Background: PubMed 30576664Simmons RG, Sanders JN, Geist C, Gawron L, Myers K, Turok DK. Predictors of contraceptive switching and discontinuation within the first 6 months of use among Highly Effective Reversible Contraceptive Initiative Salt Lake study participants. Am J Obstet Gynecol. 2019 Apr;220(4):376.e1-376.e12. doi: 10.1016/j.ajog.2018.12.022. Epub 2018 Dec 18.
- Background: PubMed 16798842Venners SA, Liu X, Perry MJ, Korrick SA, Li Z, Yang F, Yang J, Lasley BL, Xu X, Wang X. Urinary estrogen and progesterone metabolite concentrations in menstrual cycles of fertile women with non-conception, early pregnancy loss or clinical pregnancy. Hum Reprod. 2006 Sep;21(9):2272-80. doi: 10.1093/humrep/del187. Epub 2006 Jun 23.
- Background: PubMed 30791104Bradley SEK, Polis CB, Bankole A, Croft T. Global Contraceptive Failure Rates: Who Is Most at Risk? Stud Fam Plann. 2019 Mar;50(1):3-24. doi: 10.1111/sifp.12085. Epub 2019 Feb 21.
- Background: PubMed 27605641Pace LE, Dusetzina SB, Keating NL. Early Impact Of The Affordable Care Act On Oral Contraceptive Cost Sharing, Discontinuation, And Nonadherence. Health Aff (Millwood). 2016 Sep 1;35(9):1616-24. doi: 10.1377/hlthaff.2015.1624.
- Background: PubMed 30496379Duffy DM, Ko C, Jo M, Brannstrom M, Curry TE. Ovulation: Parallels With Inflammatory Processes. Endocr Rev. 2019 Apr 1;40(2):369-416. doi: 10.1210/er.2018-00075.
- Background: PubMed 15541405Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, Massai R, Faundes A, Salvatierra AM. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception. 2004 Dec;70(6):442-50. doi: 10.1016/j.contraception.2004.05.007.
- Background: PubMed 16009156Devoto L, Fuentes A, Palomino A, Espinoza A, Kohen P, Ranta S, von Hertzen H. Pharmacokinetics and endometrial tissue levels of levonorgestrel after administration of a single 1.5-mg dose by the oral and vaginal route. Fertil Steril. 2005 Jul;84(1):46-51. doi: 10.1016/j.fertnstert.2005.01.106.
- Background: PubMed 23809278Brache V, Cochon L, Deniaud M, Croxatto HB. Ulipristal acetate prevents ovulation more effectively than levonorgestrel: analysis of pooled data from three randomized trials of emergency contraception regimens. Contraception. 2013 Nov;88(5):611-8. doi: 10.1016/j.contraception.2013.05.010. Epub 2013 May 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Lukes, MD principal investigator
Carolina Woman's Research and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levonorgestrel 1.5 milligram, Meloxicam 15 milligram and calcium carbonate 750 milligram in people with Pregnancy Prevention, run by InnovaGyn, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interval From First Dose to Evidence of Ovulation. (time frame: The interval is estimated to be 3 days from first dose of placebo to evidence of ovulation, and the interval is estimated to be 7 days from first dose of intervention to evidence of ovulation. Assessment was to 10 days from first dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306131, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.