Trial · NCT05695352
Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
NCT05695352, Phase 2, Completed, InnovaGyn, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days. Trials, record NCT05695352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05695352
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days
- NCT number
- NCT05695352
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- InnovaGyn, Inc.
- Conditions
- Pregnancy Prevention
- Interventions
- Levonorgestrel 1.5mg, Meloxicam 15 mg, Placebo
- First posted
- 2023-01-25
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Interval to Ovulation in Normal Women Following Placebo is Anticipated to be Three Days Compared to Seven Days Following Levonorgestrel Plus Meloxicam | 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. | 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. |
| Secondary | Safety Using Blood Pressure, Specifically Systolic Blood Pressure | Changes in the mean sitting systolic blood pressure during the placebo and intervention menstrual cycles. For each cycle, sitting blood pressures were compared on the day of her first dose (either placebo or intervention) and ten days from the first dose. | During the placebo and intervention cycles, systolic blood pressures (mm Hg) were compared between the day of her first dose (either placebo or intervention) and ten days from the first dose. |
| Other | Menstrual Bleeding Interval for Both the Placebo and Intervention Cycle. | 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. | 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. |
| Other | Unscheduled Vaginal Bleeding | All incidences of unscheduled bleeding within the placebo and intervention cycles were collected, with each cycle approximately 28 ± 2.0 days. | Number of participants who reported unscheduled bleeding in the placebo or intervention cycles. |
| Other | Report the Number of Participants Who Reported Adverse Events in Both the Placebo and Intervention Arms | 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. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers25
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R43HD104508 | Novel On Demand Female Oral Contraceptive | ARCHER, DAVID FITZGERALD | INNOVAGYN, INC. | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05695352
GET https://conductscience.org/api/trials/v1/NCT05695352/papers?page=2