Trial Outcomes & Findings for Phase II Study of Ovulation in Obese Women (NCT NCT06306131)
NCT ID: NCT06306131
Last Updated: 2026-06-30
Results Overview
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.
COMPLETED
PHASE2
4 participants
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.
2026-06-30
Participant Flow
There were significant issues with recruitment for this study despite numerous attempts by the clinical site. After screening, two women withdrew consent and five women were screen failures.
All four women who were successfully screened were enrolled in their subsequent menstrual cycle. There was no washout period.
Participant milestones
| Measure |
Placebo in the First Menstrual Cycle Then Intervention in the Second Menstrual Cycle.
In the first menstrual cycle when a transvaginal ultrasound shows a lead ovarian follicle diameter of at least 17 mm then all participants will take one tablet of placebo, calcium carbonate 750 milligram (mg) known as TUMS, and repeat dose 48 hours later. For the second subsequent menstrual cycle when a transvaginal ultrasound shows a lead follicle diameter of at least 17 mm the participant will take the intervention, one tablet of levonorgestrel 1.5 mg and one tablet of meloxicam 15 mg, with a repeat dose 48 hours later.
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|---|---|
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Menstrual Cycle 1 (28 +/- 2 days)
STARTED
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4
|
|
Menstrual Cycle 1 (28 +/- 2 days)
COMPLETED
|
4
|
|
Menstrual Cycle 1 (28 +/- 2 days)
NOT COMPLETED
|
0
|
|
Menstrual Cycle 2 (28 +/- 2 days)
STARTED
|
4
|
|
Menstrual Cycle 2 (28 +/- 2 days)
COMPLETED
|
4
|
|
Menstrual Cycle 2 (28 +/- 2 days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Ovulation in Obese Women
Baseline characteristics by cohort
| Measure |
Placebo in the First Menstrual Cycle Then Intervention in the Second Menstrual Cycle.
n=4 Participants
During the first menstrual cycle when the lead follicle on transvaginal ultrasound measures at least 17 mm in diameter each participant will take one tablet orally of placebo and repeat 48 hours later. The placebo is calcium carbonate 750 milligrams (mg) known as TUMS.
During the subsequent second menstrual cycle when the lead follicle on transvaginal ultrasound measures at least 17 mm in diameter each participant will take one tablet of levonorgestrel 1.5 mg and one tablet of meloxicam 15 mg and repeat both tablets 48 hours later.
|
|---|---|
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Age, Continuous
|
33.75 Years
STANDARD_DEVIATION 9.84 • n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Four women finished both arms of the study but one of the participants was found to be anovulatory for both the placebo and active treatment arms and was dropped from the analysis.
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.
Outcome measures
| Measure |
Placebo
n=3 Participants
The 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
n=3 Participants
The active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later.
|
|---|---|---|
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Interval From First Dose to Evidence of Ovulation.
|
2.67 Number of days
Standard Deviation 1.53
|
4.0 Number of days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Placebo
n=4 Participants
The 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
n=4 Participants
The active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later.
|
|---|---|---|
|
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.
|
1.0 Beats per minute (BPM)
Standard Deviation 2.65
|
-6.67 Beats per minute (BPM)
Standard Deviation 11.93
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Placebo
n=4 Participants
The 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
n=4 Participants
The active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later.
|
|---|---|---|
|
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.
Diastolic blood pressure changes
|
4.33 mm Hg
Standard Deviation 17.50
|
5.0 mm Hg
Standard Deviation 5.0
|
|
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.
Systolic blood pressure changes
|
-6.0 mm Hg
Standard Deviation 11.36
|
6.67 mm Hg
Standard Deviation 2.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The participants will report on daily diary cards any bleeding from menstrual day 9 of the first cycle to the exit visit which is within two weeks of the final (third) menstrual period, an assessed time period up to 90 days.Each participant will enter on daily diary cards any unscheduled vaginal bleeding that occurs in both the placebo and active treatment cycles.
Outcome measures
| Measure |
Placebo
n=4 Participants
The 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
n=4 Participants
The active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later.
|
|---|---|---|
|
Unscheduled Vaginal Bleeding
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0 Participants
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0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Menstrual cycle intervals will be determined from Day 1 to Day 45 in both cycles, assessed up to a total of 90 days.Each participant will document the first day of their menstrual cycle so that the intermenstrual interval can be calculated for both the placebo and active treatment cycles. There might be a change in intermenstrual interval with active treatment.
Outcome measures
| Measure |
Placebo
n=4 Participants
The 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
n=4 Participants
The active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later.
|
|---|---|---|
|
Menstrual Cycle Interval
|
35.0 Days
Standard Deviation 18.13
|
26.0 Days
Standard Deviation 2.58
|
Adverse Events
Placebo in the First Menstrual Cycle.
Levonorgestrel and Meloxicam in the Second 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 of InnovaGyn II, Inc.
InnovaGyn, II, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place