Trial Outcomes & Findings for Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days (NCT NCT05695352)
NCT ID: NCT05695352
Last Updated: 2026-06-17
Results Overview
The participant will take the first dose of medication (either placebo or intervention) when an ovarian follicle measuring at least 17 mm in diameter is found on transvaginal ultrasound and a second dose 48 hours later. 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, also known as the follicular luteal shift. The interval from first dose of placebo to follicular luteal shift is estimated to be three days. The active treatment will be given the same way during the subsequent second cycle when the ovarian follicle diameter is also at least 17 mm. The intervention outcome is estimated to be a delay of seven or more days from first dose to the follicular luteal shift or ovulation.
COMPLETED
PHASE2
19 participants
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.
2026-06-17
Participant Flow
Twenty-four women were screened. Five women failed screening. Nineteen women enrolled with eighteen completing both arms of the study. One woman completed the placebo arm but did not return for the intervention cycle and was lost to follow up.
All enrolled were assigned to placebo first and then subsequently did the intervention cycle. Nineteen women started. One woman dropped out after the placebo arm. Eighteen women finished both periods.
Participant milestones
| Measure |
Participants Will Take the Placebo in the First Menstrual Cycle and the Intervention in the Second.
The two periods placebo comparator study will use each participant as her own control. The placebo arm is the first menstrual cycle after screening with the second menstrual cycle being the intervention arm. During the first menstrual cycle the participant will undergo serial transvaginal ultrasounds and when the lead ovarian follicle measures at least 17 mm in diameter she will take one placebo tablet with a second placebo 48 hours later. In the subsequent second menstrual cycle each participant will take the active intervention, one tablet of levonorgestrel 1.5 mg and one tablet of meloxicam 15 mg, when the lead ovarian follicle measures 17 mm in diameter with a second dose of each tablet 48 hours later.
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|---|---|
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Menstrual cycle 1 (28 +/- 2 days)
STARTED
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19
|
|
Menstrual cycle 1 (28 +/- 2 days)
COMPLETED
|
19
|
|
Menstrual cycle 1 (28 +/- 2 days)
NOT COMPLETED
|
0
|
|
Menstrual cycle 2 (28 +/- 2 days)
STARTED
|
19
|
|
Menstrual cycle 2 (28 +/- 2 days)
COMPLETED
|
18
|
|
Menstrual cycle 2 (28 +/- 2 days)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Participants Will Take the Placebo in the First Menstrual Cycle and the Intervention in the Second.
The two periods placebo comparator study will use each participant as her own control. The placebo arm is the first menstrual cycle after screening with the second menstrual cycle being the intervention arm. During the first menstrual cycle the participant will undergo serial transvaginal ultrasounds and when the lead ovarian follicle measures at least 17 mm in diameter she will take one placebo tablet with a second placebo 48 hours later. In the subsequent second menstrual cycle each participant will take the active intervention, one tablet of levonorgestrel 1.5 mg and one tablet of meloxicam 15 mg, when the lead ovarian follicle measures 17 mm in diameter with a second dose of each tablet 48 hours later.
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|---|---|
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Menstrual cycle 2 (28 +/- 2 days)
Lost to Follow-up
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1
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Baseline Characteristics
Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
Baseline characteristics by cohort
| Measure |
All Participants Took Placebo in the First Menstrual Cycle and Intervention in the Second Cycle.
n=19 Participants
The two periods placebo comparator study will use each participant as her own control. The placebo arm is the first menstrual cycle after screening with the second menstrual cycle being the intervention arm. During the first menstrual cycle the participant will undergo serial transvaginal ultrasounds and when the lead ovarian follicle measures at least 17 mm in diameter she will take one placebo tablet with a second placebo 48 hours later. In the subsequent second menstrual cycle each participant will take the active intervention, one tablet of levonorgestrel 1.5 mg and one tablet of meloxicam 15 mg, when the lead ovarian follicle measures at least 17 mm in diameter with a second dose of each tablet 48 hours later.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=9 Participants
|
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Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
United States
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19 Participants
n=9 Participants
|
|
Blood pressure
Systolic blood pressure
|
110.0 mm Hg
STANDARD_DEVIATION 13.24 • n=9 Participants
|
|
Blood pressure
Diastolic blood pressure
|
72.39 mm Hg
STANDARD_DEVIATION 9.15 • n=9 Participants
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PRIMARY outcome
Timeframe: 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.Population: Nineteen participants enrolled with one participant dropping out after the first placebo cycle and was not included in analysis. Another participant was removed from analysis as she was found to be anovulatory in both the placebo and treatment cycles.
The participant will take the first dose of medication (either placebo or intervention) when an ovarian follicle measuring at least 17 mm in diameter is found on transvaginal ultrasound and a second dose 48 hours later. 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, also known as the follicular luteal shift. The interval from first dose of placebo to follicular luteal shift is estimated to be three days. The active treatment will be given the same way during the subsequent second cycle when the ovarian follicle diameter is also at least 17 mm. The intervention outcome is estimated to be a delay of seven or more days from first dose to the follicular luteal shift or ovulation.
Outcome measures
| Measure |
Placebo Comparator in Normal Ovulatory Women
n=17 Participants
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 one placebo tablet taken when the lead ovarian follicle measures at least 17 mm in diameter and a second dose 48 hours later.
|
Active Intervention in Normal Ovulatory Women
n=17 Participants
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 is at least 17 mm in diameter. The two medications will be repeated 48 hours later.
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|---|---|---|
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Interval to Ovulation in Normal Women Following Placebo is Anticipated to be Three Days Compared to Seven Days Following Levonorgestrel Plus Meloxicam
|
3.53 Number of days
Standard Deviation 2.24
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5.11 Number of days
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: Changes in the mean sitting systolic blood pressure during the placebo and intervention menstrual cycles. For each cycle, sitting blood pressures were measured on the following days: first dose, second dose and ten days from first dose.During the placebo and intervention cycles, systolic blood pressures (mm Hg) were compared between the day of her first dose (either placebo and intervention) and ten days from the first dose.
Outcome measures
| Measure |
Placebo Comparator in Normal Ovulatory Women
n=18 Participants
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 one placebo tablet taken when the lead ovarian follicle measures at least 17 mm in diameter and a second dose 48 hours later.
|
Active Intervention in Normal Ovulatory Women
n=18 Participants
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 is at least 17 mm in diameter. The two medications will be repeated 48 hours later.
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|---|---|---|
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Safety Using Blood Pressure, Specifically Systolic Blood Pressure
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4.12 mm Hg
Standard Deviation 8.35
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-1.94 mm Hg
Standard Deviation 10.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: Menstrual interval for both placebo and intervention cycles; from menstrual day 1 to end of cycle in placebo compared to intervention cycle with each cycle approximately 28 ± 2.0 days. Measurements are made in up to two menstrual cycles.Population: Out of 19 women recruited one was anovulatory for both the placebo and intervention arm and one woman did not start the intervention cycle so both were dropped from the analysis.
The menstrual bleeding interval will be determined for both the placebo and intervention arms to determine whether there is an earlier onset or delay in menstrual bleeding with the intervention compared to the placebo cycle.
Outcome measures
| Measure |
Placebo Comparator in Normal Ovulatory Women
n=17 Participants
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 one placebo tablet taken when the lead ovarian follicle measures at least 17 mm in diameter and a second dose 48 hours later.
|
Active Intervention in Normal Ovulatory Women
n=17 Participants
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 is at least 17 mm in diameter. The two medications will be repeated 48 hours later.
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|---|---|---|
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Menstrual Bleeding Interval for Both the Placebo and Intervention Cycle.
|
32.95 Days
Standard Deviation 11.78
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25.82 Days
Standard Deviation 5.28
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OTHER_PRE_SPECIFIED outcome
Timeframe: All incidences of unscheduled bleeding within the placebo and intervention cycles were collected, with each cycle approximately 28 ± 2.0 days.Population: Of 19 women recruited one woman did not do the intervention cycle and was dropped from the analysis.
Number of participants who reported unscheduled bleeding in the placebo or intervention cycles.
Outcome measures
| Measure |
Placebo Comparator in Normal Ovulatory Women
n=18 Participants
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 one placebo tablet taken when the lead ovarian follicle measures at least 17 mm in diameter and a second dose 48 hours later.
|
Active Intervention in Normal Ovulatory Women
n=18 Participants
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 is at least 17 mm in diameter. The two medications will be repeated 48 hours later.
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|---|---|---|
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Unscheduled Vaginal Bleeding
|
0 Participants
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0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Events are measured from day one to end of cycle in placebo cycle compared to day one to end of cycle in the intervention cycle with each cycle anticipated to be 28 ± 2.0 days. Adverse events are collected for two menstrual cycles.Population: Of 19 women who were recruited one did not return for the intervention arm.
Incidence of nausea, abdominal cramping or vomiting is an expected side effect of both levonorgestrel and meloxicam and is not considered an adverse event. This outcome will document any emergent adverse events for both the placebo and active intervention arms.
Outcome measures
| Measure |
Placebo Comparator in Normal Ovulatory Women
n=19 Participants
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 one placebo tablet taken when the lead ovarian follicle measures at least 17 mm in diameter and a second dose 48 hours later.
|
Active Intervention in Normal Ovulatory Women
n=18 Participants
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 is at least 17 mm in diameter. The two medications will be repeated 48 hours later.
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|---|---|---|
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Report the Number of Participants Who Reported Adverse Events in Both the Placebo and Intervention Arms
|
0 Number of participants
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0 Number of participants
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Adverse Events
Placebo in the First Menstrual Cycle Then Intervention in the Second Menstrual Cycle.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David F. Archer, MD, Chief Executive Officer
InnovaGyn, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place